Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- EZTPacemaker, Bladder3Product Code
- EZWStimulator, Electrical, Implantable, For Incontinence3Product Code
- EZYDevice, Incontinence, Mechanical/Hydraulic3Product Code
- FAHDilator, Urethral, Mechanical2Product Code
- BSSTube, Nasogastric2Product Code
- EXASelector, Size, Ostomy1Product Code
- EXBCollector, Ostomy1Product Code
- EXDIrrigator, Ostomy2Product Code
- EXEProtector, Ostomy1Product Code
- EXFBag, Bile Collecting2Product Code
- EXGBag, Urine Collecting, Ureterostomy1Product Code
- EXHBag, Urinary, Ileostomy1Product Code
- EXIDevice, Paste-On For Incontinence, Sterile1Product Code
- EXJDevice, Incontinence, Urosheath Type, Sterile1Product Code
- EXNSupport, Hernia1Product Code
- EYAStylet, Ureteral1Product Code
- EYBCatheter, Ureteral, Gastro-Urology2Product Code
- EYCCatheter, Upper Urinary Tract2Product Code
- EYIAdaptor, Ureteral Catheter1Product Code
- EYJHolder, Ureteral Catheter1Product Code
- EYKConnector, Ureteral Catheter1Product Code
- EYQGarment, Protective, For Incontinence1Product Code
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile1Product Code
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile1Product Code
- EZBStylet For Catheter, Gastro-Urology1Product Code
- EZCCatheter, Coude2Product Code
- EZDCatheter, Straight2Product Code
- EZKCatheter, Retention Type2Product Code
- EZLCatheter, Retention Type, Balloon2Product Code
- EZMDilator, Esophageal (Metal Olive) Gastro-Urology2Product Code
- EZNDilator, Catheter, Ureteral2Product Code
- EZQPouch, Colostomy1Product Code
- EZRCement, Stomal Appliance, Ostomy1Product Code
- EZSAppliance, Colostomy, Disposable1Product Code
- FAQBag, Urine Collection, Leg, For External Use, Sterile1Product Code
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology2Product Code
- FAXBougie, Urological1Product Code
- FBMCannula And Trocar, Suprapubic, Non-Disposable1Product Code
- FBRUrethrometer1Product Code
- FBWFiliform And Filiform Follower1Product Code
- FBXSound, Urethral, Metal Or Plastic1Product Code
- FCBBag, Hemostatic2Product Code
- FCEEnema Kit1Product Code
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)2Product Code
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter2Product Code
- FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression2Product Code
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation2Product Code
- FEWCatheter, Malecot2Product Code
- FEXInstrument, Catheter, Punch1Product Code
- FEZCatheter And Tube, Suprapubic2Product Code
- FFATube, Drainage, Suprapubic2Product Code
- FFHCollector, Urine, Pediatric, For Indwelling Catheter2Product Code
- FFPDilator, Rectal1Product Code
- FFWString And Tubes, Gastrointestinal, To Locate Internal Bleeding2Product Code
- FGDCatheter, Retention, Barium Enema With Bag2Product Code
- FGEStents, Drains And Dilators For The Biliary Ducts2Product Code
- FGFCatheter, Ureteral Disposable (X-Ray)2Product Code
- FGHCatheter, Double Lumen Female Urethrographic2Product Code
- FGICatheter, Urethrographic, Male2Product Code
- FHAClamp, Penile1Product Code
- FHSDialyzer, Single Coil2Product Code
- FHTSet, Gavage, Infant, Sterile2Product Code
- FIAChair, Dialysis, Unpowered, Without Scales1Product Code
- FIBProtector, Transducer, Dialysis2Product Code
- FIDTubing, Dialysate2Product Code
- FIENeedle, Fistula2Product Code
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump2Product Code
- FIGClamp, Tubing, Blood, Automatic2Product Code
- FIHPump, Infusion Or Syringe, Extra-Luminal2Product Code
- FIISystem, Dialysate Delivery, Sealed2Product Code
- FIJSystem, Dialysate Delivery, Recirculating, Single Pass2Product Code
- FIKSystem, Dialysate Delivery, Recirculating2Product Code
- FILSystem, Dialysate Delivery, Single Pass2Product Code
- FINTank, Holding, Dialysis2Product Code
- FIPSubsystem, Water Purification2Product Code
- FIQCannula, A-V Shunt2Product Code
- FIRPump, Blood, Extra-Luminal2Product Code
- FISFlowmeter, Dialysate2Product Code
- FIWAlarm, Pillow Pressure2Product Code
- FIZMeter, Conductivity, Non-Remote2Product Code
- FJAManometer, Water2Product Code
- FJBDetector, Dialysate Level2Product Code
- FJCDetector, Blood Level2Product Code
- FJDDetector, Leak, Blood2Product Code
- FJFDetector, Air Bubble2Product Code
- FJGDialyzer, Parallel Flow2Product Code
- FJHDialyzer, Disposable2Product Code
- FJIDialyzer, Capillary, Hollow Fiber2Product Code
- FJJDialyzer, Twin Coil2Product Code
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2Product Code
- FJMGuard, Shunt2Product Code
- FJNStabilizer, Shunt2Product Code
- FJOPlier, Tube1Product Code
- FJPAdaptor, Y2Product Code
- FJQConnector, Shunt1Product Code
- FJRForceps, Disconnect1Product Code
- FJSCatheter, Peritoneal, Long-Term Indwelling2Product Code
- FJTIntracatheter, Dialysis2Product Code
- FJWRing, Joint1Product Code
- FJXRing, Crimp1Product Code
- FJYPlier, Crimp1Product Code
- FJZDeclotting Tray, Kit (Including Contents)2Product Code
- FKADilator, Vessel2Product Code
- FKBConnector, Blood Tubing, Infusion T2Product Code
- FKCClamp, Cannula1Product Code
- FKDCanister, Coil2Product Code
- FKETie, Dialysis1Product Code
- FKFGun, Tie, Dialysis1Product Code
- FKGTray, Start/Stop (Including Contents), Dialysis1Product Code
- FKHSolution-Test Standard-Conductivity, Dialysis2Product Code
- FKISet, Dialyzer Holder2Product Code
- FKJFilter, Blood, Dialysis2Product Code
- FKLInsert, Pump, Blood2Product Code
- FKMAdaptor, Fistula2Product Code
- FKNAdaptor, Shunt2Product Code
- FKOCatheter, Peritoneal Dialysis, Single Use2Product Code
- FKPSystem, Dialysate Delivery, Single Patient2Product Code
- FKQSystem, Dialysate Delivery, Central Multiple Patient2Product Code
- FKRSubsystem, Proportioning2Product Code
- FKTSystem, Dialysate Delivery, Sorbent Regenerated2Product Code
- FKWTip, Vessel2Product Code
- FKXSystem, Peritoneal, Automatic Delivery2Product Code
- FKYConnector, Tubing, Dialysate2Product Code
- FLAMonitor, Temperature, Dialysis2Product Code
- FLBMeter, Conductivity, Induction, Remote Type2Product Code
- FLCStation, Dialysis Control, Negative Pressure Type2Product Code
- FLDApparatus, Hemoperfusion, Sorbent2Product Code
- FOCBag, Urine Collection, Newborn2Product Code
- FONBag, Drainage, With Adhesive, Ostomy1Product Code
- FPDTube, Feeding2Product Code
- FRQTube, Levine2Product Code
- GBLCatheter, Ureteral, General & Plastic Surgery2Product Code
- GBMCatheter, Urethral2Product Code
- GBTCatheter, Rectal2Product Code
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection2Product Code
- GDSBag, Stomal1Product Code
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration2Product Code
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2Product Code
- K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)2Cleared 510(K)
- K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)2Cleared 510(K)
- K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)2Cleared 510(K)
- K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)2Cleared 510(K)
- K233798Moda-flx Hemodialysis System and Cartridge2Cleared 510(K)
- K233557HemoCare Hemodialysis System2Cleared 510(K)
- K240394multiFlux 1000 (F00012408)2Cleared 510(K)
- K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer2Cleared 510(K)
- K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)2Cleared 510(K)
- K232171Purema® H Hemoconcentrator (EtO Sterilized)2Cleared 510(K)
- K2315345008X Hemodialysis System2Cleared 510(K)
- K2311252008T BlueStar Hemodialysis Machine2Cleared 510(K)
- K233335Tablo® Hemodialysis System2Cleared 510(K)
- K232467CleanCart A, CleanCart C, AK 98 Hemodialysis Machine2Cleared 510(K)
- K230632VersiHD with GuideMe software2Cleared 510(K)
- K223248Tablo® Hemodialysis System2Cleared 510(K)
- K231406ClearumTM HS2Cleared 510(K)
- K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 10002Cleared 510(K)
- K220281multiFiltratePRO System2Cleared 510(K)
- K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set2Cleared 510(K)
- K2229522008T BlueStar Hemodailysis Machine2Cleared 510(K)
- K211370Tablo Hemodialysis System2Cleared 510(K)
- K210575HDF Assist Mudule, HDF Infusion Set and Substitution Filter2Cleared 510(K)
- K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set2Cleared 510(K)
- K213639Revaclear 500, Revaclear 400, Revaclear 3002Cleared 510(K)
- K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset2Cleared 510(K)
- K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory2Cleared 510(K)
- K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NR2Cleared 510(K)
- K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set2Cleared 510(K)
- K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 222Cleared 510(K)
- K192707Optiflux F180NR Dialyzer2Cleared 510(K)
- K193005DIMI RRT System2Cleared 510(K)
- K192928Optiflux Enexa F500 Dialyzer2Cleared 510(K)
- K200741Tablo Hemodialysis System2Cleared 510(K)
- K193482PrisMax System Version 32Cleared 510(K)
- K192756Aquadex FlexFlow System 2.02Cleared 510(K)
- K190793Tablo Hemodialysis System, Tablo Cartridge2Cleared 510(K)
- K183158NxStage Cartridge Express with Speedswap2Cleared 510(K)
- K190910PrisMax System Version 22Cleared 510(K)
- K182940Surdial DX Hemodialysis System2Cleared 510(K)
- K1739722008T BlueStar Hemodialysis Machine2Cleared 510(K)
- K171671Prismaflex System 8.102Cleared 510(K)
- K170790SAM CRRT Unit, SAM Cassette CRRT2Cleared 510(K)
- K171331NxStage System One2Cleared 510(K)
- K170574Diacap Pro Dialyzer2Cleared 510(K)
- K170469NxStage System One Plus2Cleared 510(K)
- K163530PrisMax Control Unit2Cleared 510(K)
- K162248Asahi ViE-U Series Dialyzer2Cleared 510(K)
- K162488Optiflux dialyzer2Cleared 510(K)
- K160444FB-U Hemodialyzer2Cleared 510(K)
- K160558RAPIDO HOLLOW-FIBRE DIALYZERS2Cleared 510(K)
- K160881Tablo Console2Cleared 510(K)
- K1534492008K2 Hemodialysis Machine2Cleared 510(K)
- K152938DBB-06 Hemodialysis Delivery System2Cleared 510(K)
- K143482xevonta dialyzer2Cleared 510(K)
- K153344Asahi REXEED-S Series Dialyzer2Cleared 510(K)
- K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine2Cleared 510(K)
- K152367Optiflux dialyzer2Cleared 510(K)
- K150880Tablo Console with Wireless Capability2Cleared 510(K)
- K143313NxStage Therapeutic Plasma Exchange (TPE) Cartridge2Cleared 510(K)
- K140866TABLO CONSOLE2Cleared 510(K)
- K133299ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY2Cleared 510(K)
- K140526NXSTAGE SYSTEM ONE2Cleared 510(K)
- K140191ELISIO-H HEMODIALYZER2Cleared 510(K)
- K133547NXSTAGE SYSTEM ONE WITH NXVIEW2Cleared 510(K)
- K132602STREAMLINE EXPRESS2Cleared 510(K)
- K123262OPTIFLUX ULTRA DIALYZER2Cleared 510(K)
- K131516PRISMAFLEX SYSTEM 7.102Cleared 510(K)
- K131050NXSTAGE 1.6M2 DIALYZER2Cleared 510(K)
- K131935ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER2Cleared 510(K)
- K131381ELISIO-H HEMODIALYZER2Cleared 510(K)
- K1319082008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)2Cleared 510(K)
- K123288HEMOCONCENTRATOR2Cleared 510(K)
- K122343PUREFLUX-H HEMODIALYZER2Cleared 510(K)
- K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER2Cleared 510(K)
- K122347ELISIO-H AND ELISIO-M HEMODIALYZERS2Cleared 510(K)
- K122051NXSTAGE SYSTEM ONE2Cleared 510(K)
- K123395NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS2Cleared 510(K)
- K121409ASAHI REXEED-SX/LX SERIES DIALYZER2Cleared 510(K)
- K113023STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER2Cleared 510(K)
- K121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM2Cleared 510(K)
- K121497VENOFER PUMP2Cleared 510(K)
- K112314NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER2Cleared 510(K)
- K120505FRESENIUS 2008T HEMODIALYSIS MACHINE2Cleared 510(K)
- K120017FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM2Cleared 510(K)
- K113427FRESENIUS 2008T HEMODIALYSIS MACHINE2Cleared 510(K)
- K111639FRESENIUS 2008T HEMODIALYSIS MACHINE2Cleared 510(K)
- K110823PRISMAFLEX2Cleared 510(K)
- K103832PHOENIX HEMODIALYSIS DELIVERY SYSTEM2Cleared 510(K)
- K103564VENOFER PUMP2Cleared 510(K)
- K101715FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 1905732Cleared 510(K)
- K093069NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE2Cleared 510(K)
- K093964VENOFER PUMP2Cleared 510(K)
- K093902MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 1905732Cleared 510(K)
- K100334DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 720368112Cleared 510(K)
- K091978DBB-06 HEMODIALYSIS DELIVERY SYSTEM2Cleared 510(K)
- K083460DIALOG WITH ADIMEA OPTION2Cleared 510(K)
- K093120XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 1702Cleared 510(K)
- K093379TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM2Cleared 510(K)
- K090682EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-002Cleared 510(K)
- K083158EXALIS, SOFTWARE VERSION 1.152Cleared 510(K)
- K083778XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 2102Cleared 510(K)
- K080964FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE2Cleared 510(K)
- K080650OMNI-DL SYSTEM2Cleared 510(K)
- K081313SH14 HEMOCONCENTRATOR2Cleared 510(K)
- K082414OPTIFLUX F250NR, MODEL 0500325E2Cleared 510(K)
- K082515ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX2Cleared 510(K)
- K080519PRISMAFLEX M150 SET2Cleared 510(K)
- K072093PRISMAFLEX SYSTEM, VERSION 3.202Cleared 510(K)
- K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.352Cleared 510(K)
- K061519MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM2Cleared 510(K)
- K072232GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL2Cleared 510(K)
- K071854AQUADEX FLEXFLOW SYSTEM2Cleared 510(K)
- K071263NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-5002Cleared 510(K)
- K071518DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS2Cleared 510(K)
- K071298HF JUNIOR HEMOFILTER2Cleared 510(K)
- K070320EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 012Cleared 510(K)
- K070512MODIFICATION TO AQUADEX FLEXFLOW SYSTEM2Cleared 510(K)
- K070222FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N2Cleared 510(K)
- K063183PRISMA M10 PRE SET2Cleared 510(K)
- K062922MODIFICATION TO AQUADEX FLEXFLOW SYSTEM2Cleared 510(K)
- K062079XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 2102Cleared 510(K)
- K062090PRISMA SYSTEM R03.10A2Cleared 510(K)
- K061837NXSTAGE CARTRIDGE EXPRESS2Cleared 510(K)
- K053539MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M55762Cleared 510(K)
- K060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE2Cleared 510(K)
- K060008AQUADEX FLEXFLOW SYSTEM2Cleared 510(K)
- K050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR2Cleared 510(K)
- K051520GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H2Cleared 510(K)
- K050609AQUADEX SYSTEM2Cleared 510(K)
- K050525NXSTAGE SYSTEM ONE2Cleared 510(K)
- K050727MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS2Cleared 510(K)
- K050603OLPUR DIALYZER, MODEL HD 1902Cleared 510(K)
- K051187REXEED SERIES DIALYZERS2Cleared 510(K)
- K042938GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS2Cleared 510(K)
- K043244FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR2Cleared 510(K)
- K041005GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS2Cleared 510(K)
- K041726HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX2Cleared 510(K)
- K041424NXSTAGE SYSTEM ONE2Cleared 510(K)
- K040696MODIFICATION TO NXSTAGE SYSTEM ONE2Cleared 510(K)
- K040255POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE2Cleared 510(K)
- K040489AQUADEX SYSTEM 100, MODEL A11002Cleared 510(K)
- K034064FRESENIUS ULTRAFLO HPX HEMODIALYZER2Cleared 510(K)
- K023874SYSTEM 100 ULTRAFILTRATION CATHETER2Cleared 510(K)
- K023509DBB-05 HEMODIALYSIS DELIVERY SYSTEM2Cleared 510(K)
- K032356NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS2Cleared 510(K)
- K030050TORAYSULFONE DIALYZER, BS-L SERIES2Cleared 510(K)
- K032431PRISMA M60/M100 SETS2Cleared 510(K)
- K030099BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 15712780002Cleared 510(K)
- K031378FRESENIUS ULTRAFLUX HEMODIALYZER2Cleared 510(K)
- K030592GAMBRO POLYFLUX, MODEL 140H, 170H, 210H2Cleared 510(K)
- K030974EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 1702Cleared 510(K)
- K030975EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 2102Cleared 510(K)
- K024124SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT2Cleared 510(K)
- K023664SYNTRA + DIALYZER, MODEL 2002Cleared 510(K)
- K013562AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE2Cleared 510(K)
- K014152NXSTAGE CARTRIDGE EXPRESS2Cleared 510(K)
- K021615BAXTER ACCURA SYSTEM, MODEL 5M56602Cleared 510(K)
- K021732DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT2Cleared 510(K)
- K023224INFUSION CATHETER EXTENSION SET2Cleared 510(K)
- K010805PRISMA SYSTEM2Cleared 510(K)
- K013418AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY2Cleared 510(K)
- K013733SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET2Cleared 510(K)
- K020858NXSTAGE THERAPY SYSTEM2Cleared 510(K)
- K010131PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB2Cleared 510(K)
- K011269LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR2Cleared 510(K)
- K011537DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS2Cleared 510(K)
- K013550CLIRANS E-SERIES DIALYZER2Cleared 510(K)
- K011221PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET2Cleared 510(K)
- K012510MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM2Cleared 510(K)
- K002512TORAYSULFONE DIALYZER2Cleared 510(K)
- K010985GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L2Cleared 510(K)
- K010667GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R2Cleared 510(K)
- K003023COBE HC 700 MIDI HEMOCONCENTRATOR2Cleared 510(K)
- K000724MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 3002Cleared 510(K)
- K002210SYNTRA DIALYZER, MODEL SYNTRA 120, 1602Cleared 510(K)
- K003425CLIRANS E-SERIES HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K001283LIFEMATE HEMOFILTRATION SYSTEM2Cleared 510(K)
- K003498FRESENIUS OPTIFLUX 200A2Cleared 510(K)
- K002277FRESENIUS OPTIFLUX 200NR2Cleared 510(K)
- K994198HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L2Cleared 510(K)
- K001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)2Cleared 510(K)
- K001156PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET2Cleared 510(K)
- K001422PSN HEMODIALYZER, MODELS PSN 170, PSN 2102Cleared 510(K)
- K000028RENAFLO II HF 2000 HEMOFILTER2Cleared 510(K)
- K994267FRESENIUS 2008K2Cleared 510(K)
- K992573AF-220 HEMODIALYZER2Cleared 510(K)
- K992563A-22 HEMODIALYZER2Cleared 510(K)
- K992564AF-180 HEMODIALYZER2Cleared 510(K)
- K992566AF-150 HEMODIALYZER2Cleared 510(K)
- K990643PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-0152Cleared 510(K)
- K992894MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M55762Cleared 510(K)
- K993064PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)2Cleared 510(K)
- K982926FRESENIUS BLOOD VOLUME MONITOR2Cleared 510(K)
- K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS2Cleared 510(K)
- K991520FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION2Cleared 510(K)
- K982413COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS2Cleared 510(K)
- K982134DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-8512Cleared 510(K)
- K982414GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS2Cleared 510(K)
- K980386HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)2Cleared 510(K)
- K983085HEMOCOR HPH 700 HEMOCONCENTRATOR2Cleared 510(K)
- K973322DIAPACT CRRT2Cleared 510(K)
- K982760COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET2Cleared 510(K)
- K981681PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)2Cleared 510(K)
- K974652BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER2Cleared 510(K)
- K963440DIALOG DIALYSIS MACHINE2Cleared 510(K)
- K980656PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M2362Cleared 510(K)
- K974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS2Cleared 510(K)
- K980859HEMOCOR HPH MINI HEMOCONCENTRATOR2Cleared 510(K)
- K973516CAPIOX HEMOCONCENTRATOR2Cleared 510(K)
- K970253COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET2Cleared 510(K)
- K970591BLOOD MONITOR PUMP2Cleared 510(K)
- K971180BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT2Cleared 510(K)
- K970739RMI HEMOCONCENTRATOR PREFERENCE PACK2Cleared 510(K)
- K9614652008H ON LINE CLEARANCE MONITOR2Cleared 510(K)
- K970446DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM2Cleared 510(K)
- K964922DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM2Cleared 510(K)
- K955592COBE CENTRYSYSTEM 14 PES HEMODIALYZERS2Cleared 510(K)
- K955487GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS2Cleared 510(K)
- K963203BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT2Cleared 510(K)
- K953996NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS2Cleared 510(K)
- K946279PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)2Cleared 510(K)
- K955384DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION2Cleared 510(K)
- K962707MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET2Cleared 510(K)
- K962427COBE CENTRYSYSTEM 700 HG HEMODIALYZER2Cleared 510(K)
- K960474COBE CENTRYSYSTEM 600 HG HEMODIALYZERS2Cleared 510(K)
- K954987ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM2Cleared 510(K)
- K951311GAMBRO HC 14R HEMOCONCENTRATOR2Cleared 510(K)
- K952983ALTR NOVA 110 HEMODIALYZER2Cleared 510(K)
- K952978ALTRA FLUX 110 HEMODIALYZER2Cleared 510(K)
- K952982ALTREX 110 HEMODIALYZER2Cleared 510(K)
- K952342GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS2Cleared 510(K)
- K945747GAMBRO LUNDIA 94-600 DIALYZER2Cleared 510(K)
- K951344RMI HEMOCONCENTRATOR2Cleared 510(K)
- K942681FILTRYZER2Cleared 510(K)
- K945625ALTRA NOVA(TM) 140 HEMODIALYZER2Cleared 510(K)
- K945621ALTRA NOVA(TM) 170 HEMODIALYZER2Cleared 510(K)
- K945542ALTRA FLUX(TM) 170 HEMODIALYZER2Cleared 510(K)
- K945620ALTRA FLUX(TM) 140 HEMODIALYZER2Cleared 510(K)
- K950522CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER2Cleared 510(K)
- K933883GAMBRO FH 66 D HEMOFILTER2Cleared 510(K)
- K945595ALTREX(R) 200 HEMODIALYZER2Cleared 510(K)
- K945596ALTRES(R) 140 HEMODIALYZER2Cleared 510(K)
- K945597ALTRES(R) 170 HEMODIALYZER2Cleared 510(K)
- K926379ALTRA NOVA 200 HEMODAILYZER2Cleared 510(K)
- K926373ALTRA FLUX 200 HEMODIALYZER2Cleared 510(K)
- K933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER2Cleared 510(K)
- K926568BAXTER CT DIALYZER2Cleared 510(K)
- K920757FILTRAL HEMODIALYZERS2Cleared 510(K)
- K923727PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 20002Cleared 510(K)
- K931720LUNDIA ALPHA 700 HEMODIALYZER2Cleared 510(K)
- K924437HEMOSPAL KIT B22 / MULTIFLOW 60 KIT2Cleared 510(K)
- K923312HIGH PERMEABILITY DIALYER2Cleared 510(K)
- K923139HEMOCOR HP HEMOCONCENTRATOR SERIES2Cleared 510(K)
- K921134FRESENIUS POLYSULFONE DIALYZERS2Cleared 510(K)
- K914020MODIFIED ASAHI PAN-SERIES HEMOFILTERS2Cleared 510(K)
- K914363PERITONEAL DIALYSIS CYCLER SET2Cleared 510(K)
- K913950DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY2Cleared 510(K)
- K911603HEMOSPAL KIT B222Cleared 510(K)
- K911094INPERSOL CAPD BIOCAP ADMINISTRATION SET2Cleared 510(K)
- K910236RENAFLO HDF 1350 HEMODIAFILTER2Cleared 510(K)
- K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q2Cleared 510(K)
- K902837AMICON DIAFILTER 30 HEMOCONCENTRATOR2Cleared 510(K)
- K900018HOLLOW FIBER DIALYZER, BIO CARE PS 1302Cleared 510(K)
- K900918GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER2Cleared 510(K)
- K901286AMICON HEMOCONCENTRATOR SET2Cleared 510(K)
- K895405AMICON MINIFILTER PLUS HEMOFILTER2Cleared 510(K)
- K895759HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H2Cleared 510(K)
- K893742FILTRAL TM 20 HEMODIALYZER/FILTER2Cleared 510(K)
- K892262FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M2Cleared 510(K)
- K883407TORAY FILTRYZER BK SERIES2Cleared 510(K)
- K890315CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G2Cleared 510(K)
- K884365MULTIFLOW(TM) 60 KIT2Cleared 510(K)
- K884353ULTRX(TM) 850 ARTIFICIAL KIDNEY2Cleared 510(K)
- K884326FILTRAL TM 8 HEMODIALYZER2Cleared 510(K)
- K883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT2Cleared 510(K)
- K883195FRESENIUS F8 DIALYZER2Cleared 510(K)
- K872767FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER2Cleared 510(K)
- K873887MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.2Cleared 510(K)
- K872456HEMOCOR PLUS HEMOCONCENTRATOR2Cleared 510(K)
- K871108GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER2Cleared 510(K)
- K870724FRESENIUS HEMOFLOW F60 AND F802Cleared 510(K)
- K864587FRESENIUS ULTRAFLUX AV400, AV6002Cleared 510(K)
- K863961HOSPAL BIOSPAL 1800S2Cleared 510(K)
- K864169FRESENIUS HEMOFLOW F50 & F702Cleared 510(K)
- K863823AMICON DIAFILTER HEMOFILTER2Cleared 510(K)
- K861776HIGH EFFICIENCY HEMODIALYSIS SYSTEM2Cleared 510(K)
- K861106FRESENIUS HEMOFLOW F80 DIALYZER2Cleared 510(K)
- K860938GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS2Cleared 510(K)
- K855251MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS2Cleared 510(K)
- K854586HOLLOW FIBER DIALYZER2Cleared 510(K)
- K854309GAMBRO BLOOD CONCENTRATOR SETS 16,60,2002Cleared 510(K)
- K854011RENALFO HEMOFILTER CAVHD2Cleared 510(K)
- K853510MINIFILTER HEMOFILTER2Cleared 510(K)
- K852885FILTRAL HEMODIALYZER2Cleared 510(K)
- K853333DIMENSION TOTAL HIP PROSTHESIS2Cleared 510(K)
- K850979HEMOCONCENTRATOR KIT2Cleared 510(K)
- K852251FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F402Cleared 510(K)
- K844790RENAFLO HEMOCONCENTRATOR2Cleared 510(K)
- K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L2Cleared 510(K)
- K844663ASAHI NEW PAN-SERIES HEMOFILTERS2Cleared 510(K)
- K843014FRESENIUS HAEMODIALYSIS A20082Cleared 510(K)
- K841585AMER. BENTLEY CONTINU-BLOOD PROCESSOR-2Cleared 510(K)
- K841152HOSPAL BIOSPAL SCU/CAVH KIT2Cleared 510(K)
- K840680CENTRY 2000 DIALYSIS CONTROL UNIT2Cleared 510(K)
- K840543BLOOD CONCENTRATOR 1402Cleared 510(K)
- K840449AMICON DIAFILTER 40. HEMOFILTER2Cleared 510(K)
- K834589BIOSPAL (R) 1800S2Cleared 510(K)
- K831784HEMOFILTRATION SYSTEM2Cleared 510(K)
- K832547ULTRAFILTRATION CONTROLLER2Cleared 510(K)
- K832659BIOSPAL 1200S2Cleared 510(K)
- K832645BIOSPAL 3000 S2Cleared 510(K)
- K830595MONITRAL2Cleared 510(K)
- K830487HEMO-PROCESSING SYSTEM2Cleared 510(K)
- K830596ULTRAFILTRATION MONITOR UFM-10-22Cleared 510(K)
- K830648H12072Cleared 510(K)
- K830647H12102Cleared 510(K)
- K830284FH 101, FH 202 & FH 303 FIBER HEMOFILTER2Cleared 510(K)
- K823881ARTERIOVENOUS BLOOD TUBING SET FOR2Cleared 510(K)
- K823338COBE HEMOCONCENTRATOR 1.32Cleared 510(K)
- K823589H 12 072Cleared 510(K)
- K823288AMICON DIAFILTERS 20 & 30 HEMOFILTERS2Cleared 510(K)
- K813591HEMOFILTERS2Cleared 510(K)
- K820243CONTINUOUS BLOOD PROCESSOR CBP-6000 &2Cleared 510(K)
- K812575MODEL H12-102Cleared 510(K)
- K811830C-DAK DUO-FLUX ARTIFICIAL KIDNEY2Cleared 510(K)
- K811944GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER2Cleared 510(K)
- K801479GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-2Cleared 510(K)
- K801480GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ2Cleared 510(K)
- K801731C-DAK DUO-FLUX ARTIFICIAL KIDNEY2Cleared 510(K)
- K800536MODEL H 607-.67M2 30 MICRON RP AN69 MEM2Cleared 510(K)
- K801303MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST2Cleared 510(K)
- K790827RP-610 PARALLEL PLATE DIALYZER2Cleared 510(K)
- K781464HEMODIALYZER, MODEL RP610, RP AN 692Cleared 510(K)
- K780527CORTRAL I2Cleared 510(K)
- KDJSet, Administration, For Peritoneal Dialysis, Disposable2Product Code
- KDKContainer, Transport, Kidney2Product Code
- KDLSet, Perfusion, Kidney, Disposable2Product Code
- KDNSystem, Perfusion, Kidney2Product Code
- KGCTube, Gastro-Enterostomy2Product Code
- KNQDilator, Esophageal2Product Code
- KNRAdapter, A-V Shunt Or Fistula2Product Code
- KNTTubes, Gastrointestinal (And Accessories)2Product Code
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter2Product Code
- KNYAccessories, Catheter, G-U2Product Code
- KNZAccessories, A-V Shunt2Product Code
- KOBCatheter, Suprapubic (And Accessories)2Product Code
- KOCAccessories, Blood Circuit, Hemodialysis2Product Code
- KODCatheter, Urological2Product Code
- KOEDilator, Urethral2Product Code
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal2Product Code
- KPHCatheter, Rectal For Continent Ileostomy1Product Code
- KPIStimulator, Electrical, Non-Implantable, For Incontinence2Product Code
- KPLColonic Irrigation System2Product Code
- KPMShunt, Peritoneal2Product Code
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2Product Code
- KPPPeritoneal Dialysate Filter2Product Code
- KQQTubing, Dialysate (And Connector)2Product Code
- KQRDetector, Air Or Foam2Product Code
- KXMSystem Accessories, Extracorporeal2Product Code
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)2Product Code
- LCGIntestinal Splinting Tubes2Product Code
- LFJCatheter, Subclavian2Product Code
- LFKCatheter, Femoral2Product Code
- LIFDialyzer Reprocessing System2Product Code
- LJHSystem, Irrigation, Urological2Product Code
- LKYDevice, External Penile Rigidity2Product Code
- LLBSystem, Blood, Extracorporeal And Accessories2Product Code
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological2Product Code
- LQRDislodger, Stone, Biliary2Product Code
- LRIPh Meter For Dialysis Hydrogen Ion Concentration2Product Code
- MJCCatheter, Urological (Antimicrobial) And Accessories2Product Code
- MLWWarmer, Peritoneal Dialysate2Product Code
- MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female1Product Code
- MNVStrip, Dialysate Ph Indicator2Product Code
- MONSystem, Hemodialysis, Remote Accessories1Product Code
- MPBCatheter, Hemodialysis, Non-Implanted2Product Code
- MQSSystem, Hemodialysis, Access Recirculation Monitoring2Product Code
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation2Product Code
- MSDCatheter, Hemodialysis, Implanted2Product Code
- MSEHemodialyzer, Re-Use, Low Flux2Product Code
- MSFHemodialyzer, Re-Use, High Flux2Product Code
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant2Product Code
- MSZStrip, Test, Reagent, Residuals For Dialysate2Product Code
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction2Product Code
- NDSMedia, Culture, Ex Vivo, Tissue And Cell2Product Code
- NFKKit, Repair, Catheter, Hemodialysis2Product Code
- NHVSystem, Water Purification, General Medical Use2Product Code
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted2Product Code
- NIFCatheter, Hemodialysis, Triple Lumen, Implanted2Product Code
- NMLCatheter, Biliary, Reprocessed2Product Code
- NNENeedle, Fistula, Reprocessed2Product Code
- NNGSet, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed2Product Code
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile1Product Code
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile1Product Code
- NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NOADevice, Paste-On For Incontinence, Non-Sterile1Product Code
- NOOClamp, Dialysis Arm1Product Code
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia2Product Code
- NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use2Product Code
- NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator2Product Code
- NUBColonic Irrigation System, General Well Being3Product Code
- NYUCatheter, Hemodialysis, Implanted, Coated2Product Code
- NWOKit, Catheter, Urinary (Exludes Hiv Testing)2Product Code
- NWPSuprapubic Cystostomy Catheter Kit2Product Code
- NWQKit, Catheter, External, Male (Excludes Hiv Testing)2Product Code
- NWRKit, Catheter, Foley (Excludes Hiv Testing)2Product Code
- NZUCollector, Urine, Powered, Non Indwelling Catheter1Product Code
- ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System2Product Code
- ODXAutonomous Extracorporeal Blood Leak Detector/Alarm2Product Code
- OHRCatheter Care Tray2Product Code
- ONWHemodialysis System For Home Use2Product Code
- ONYOral Removable Retainer For Weight Management2Product Code
- PBPRectal Insert2Product Code
- PCUPancreatic Stent, Covered, Metallic, Removable2Product Code
- PEHHemodialysis Catheter Luer End Cap2Product Code
- PEVDialysis Administration Kit2Product Code
- PEWImplantable Transprostatic Tissue Retractor System2Product Code
- PFHVenous Window Needle Guide2Product Code
- PIAVibrator For Climax Control Of Premature Ejaculation2Product Code
- PIDEsophageal Dilator Balloon With Or Without Electrode Sensors2Product Code
- PIEEsophageal Dilator With Balloon And Electrode Sensors2Product Code
- PIFGastrointestinal Tubes With Enteral Specific Connectors2Product Code
- QGCSuprapubic Catheter Accessories1Product Code
- PIHUrethral Insert With Pump For Bladder Drainage2Product Code
- PINKidney Perfusion Kit2Product Code
- PIOEnteral Specific Transition Connectors2Product Code
- PJHDynamic Rectal Control System2Product Code
- PKIFully Subcutaneous Implanted Hemodialysis Catheter2Product Code
- PLIGastrointestional Tube Holder2Product Code
- PLQEnzyme Packed Cartridge2Product Code
- PNBBiliary Stent System For Benign Strictures2Product Code
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling2Product Code
- PNREnteral Syringes With Enteral Specific Connectors2Product Code
- QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss2Product Code
- PPABladder Irrigation Kit2Product Code
- PPBFoley Catheter Kit (Excludes Hiv Testing)2Product Code
- PPCMale External Catheterization Kit (Excludes Hiv Testing)2Product Code
- PPDUniversal Drainage Tray2Product Code
- PPFUrinary Irrigation Kit2Product Code
- PPGUrinary Drainage Collection Kit2Product Code
- PPHSingle Needle With Uni-Directional Pump Kit2Product Code
- PPIHemodialysis Tray (Not A Start/Stop Kit)2Product Code
- PPJPeritoneal Dialysis Administration Kit2Product Code
- PPKPeritoneal Dialysis Tubing Kit2Product Code
- PPLSingle Needle (Co-Axial Flow) Dialysis Kit2Product Code
- PPOMulti-Lumen Hemodialysis Catheterization Kit2Product Code
- PQEOstomy Care Kit1Product Code
- PRMEnteral Administration Kit (Adult & Pediatric)2Product Code
- PROAnti-Regurgitation Blood Tubing Kit2Product Code
- PRPBalloon Gastrostomy Tube Kit2Product Code
- PRQEsophageal Dilator Kit2Product Code
- PRRFeeding Tube Kit2Product Code
- PRSGastric Colonic Catheter Irrigation Kit2Product Code
- PRTGastric Irrigation And Aspiration Kit2Product Code
- PRWGastrointestinal Tube Kit2Product Code
- PRXGastrostomy Guide Wire Placement Kit2Product Code
- PRYGastrostomy Jejunostomy Feeding Tube Kit2Product Code
- PRZGastrostomy Tube Kit2Product Code
- PSALaparoscopic Jejunostomy Kit2Product Code
- PSBNasogastric Feed Tube Kit2Product Code
- PSCNasogastric-Gastrojejunal Kit2Product Code
- PSDLaparoscopic Gastrostomy Kit2Product Code
- PSENeedle Catheter Jejunostomy Kit2Product Code
- PSFNon-Balloon Replacement Gastrostomy System2Product Code
- PSGPercutaneous Endoscopic Gastrostomy Kit2Product Code
- PSHPercutaneous Replacement Gastrostomy Tube Kit2Product Code
- PSJRectal Dilator Kit1Product Code
- PSKReplacement Gastrostomy Feeding Catheter Tray2Product Code
- PSXChlorine Meter2Product Code
- PTKPediatric Esophageal Atresia Anastomosis Device3Product Code
- PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt2Product Code
- PTUCatheter, Peritoneal, Long-Term Indwelling, Exempt2Product Code
- PTVCatheter, Peritoneal Dialysis, Single Use, Exempt2Product Code
- PTWSystem, Peritoneal, Automatic Delivery, Exempt2Product Code
- QAJCutaneous Electrode Stimulator For Urinary Incontinence2Product Code
- QAXHemodialyzer With Expanded Solute Removal Profile2Product Code
- QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories1Product Code
- QGEBiliary Stent, Drain, And Dilator Accessories1Product Code
- QIRPediatric Hemodialysis System2Product Code
- QMYComputerized Behavioral Therapy Device For Treating Symptoms2Product Code
- QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence3Product Code
- QRCNon-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation2Product Code
- SCTFoley Catheters And Accessories With Additional Safety Features2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
5008X Hemodialysis System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K231534
- 510(k) Type
- Traditional
- Applicant
- Fresenius Medical Care
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/2/2024
- Days to Decision
- 248 days
- Submission Type
- Summary