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
- 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
- K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU2Cleared 510(K)
- K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)2Cleared 510(K)
- K231589Blood Tubing Lines for Hemodialysis AV06C-E2Cleared 510(K)
- K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series2Cleared 510(K)
- K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line2Cleared 510(K)
- K172238CAREline Airless Hemodialysis Blood Tubing Sets2Cleared 510(K)
- K160749CRIT-LINE III Blood Chamber II2Cleared 510(K)
- K152953CRIT-LINE CLIP (CLIC) BLOOD CHAMBER2Cleared 510(K)
- K141997CRIT-LINE IV SYSTEM2Cleared 510(K)
- K141281CRIT-LINE CLIP (CLIC) BLOOD CHAMBER2Cleared 510(K)
- K121599CRIT-LINE CLIP (CLIC)2Cleared 510(K)
- K082719NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P2Cleared 510(K)
- K081740HEMOBAND, MODELS HB-NS AND HB-NSXL2Cleared 510(K)
- K082758PRISMAFLO II2Cleared 510(K)
- K081043LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT2Cleared 510(K)
- K071909PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R2Cleared 510(K)
- K030456VASC-ALERT2Cleared 510(K)
- K022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR2Cleared 510(K)
- K020103PRISMAFLO2Cleared 510(K)
- K003712MODIFICATION TO MALE TO MALE LUER ADAPTER2Cleared 510(K)
- K010268FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-92Cleared 510(K)
- K002816TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV2Cleared 510(K)
- K002372ACCESS ALERT GAUGE2Cleared 510(K)
- K994306REVERSO2Cleared 510(K)
- K983707JMS DIALYZER PRIMING SET2Cleared 510(K)
- K972206NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS2Cleared 510(K)
- K971860MEDISYSTEMS DIALYSIS PRIMING SETS2Cleared 510(K)
- K954676NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS2Cleared 510(K)
- K964041CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS2Cleared 510(K)
- K955277ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS2Cleared 510(K)
- K952572DIALYSIS ADMINISTRATION KITS2Cleared 510(K)
- K950282KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA2Cleared 510(K)
- K941851DUAL LUMEN CATHETER (DLC) TRAY2Cleared 510(K)
- K941543DIAL MEDICAL KIT2Cleared 510(K)
- K941803PRISM MEDICAL CUSTOM DIALYSIS KIT2Cleared 510(K)
- K935958CRIT-LINE BLOOD CHAMBER WITH E-BEAM2Cleared 510(K)
- K926374SILICONE CATHETER REPAIR KITS2Cleared 510(K)
- K925522CENTRYSYSTEM 3 WITH CHARTS/BP OPTION2Cleared 510(K)
- K925654CD HOME DIALYSERVICE HEMODIALYSIS TRAY2Cleared 510(K)
- K924436BARD UROTRACK II MONITORING2Cleared 510(K)
- K911230RS-10002Cleared 510(K)
- K920671DIGI -FLOW2Cleared 510(K)
- K920614HEMO-BAND2Cleared 510(K)
- K912374BARD(R) UROTACK(R) 210 MONITORING SYSTEM2Cleared 510(K)
- K913361DRAIN/PRIMING/RECIRCULATION BAG2Cleared 510(K)
- K911315EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT2Cleared 510(K)
- K913483MINNILERT(R) PRESSURE MONITOR2Cleared 510(K)
- K911106MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG2Cleared 510(K)
- K910641INTRODUCER NEEDLES2Cleared 510(K)
- K910321Y ADAPTOR2Cleared 510(K)
- K902588BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD2Cleared 510(K)
- K900306HEMODIALYSIS BLOOD LINES2Cleared 510(K)
- K895244MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.2Cleared 510(K)
- K895882JMS DIALYZER PRIMING SET2Cleared 510(K)
- K896006DIALYSIS PRIMING SETS CODES 5C4094 AND 5C40952Cleared 510(K)
- K894637NATIONAL MEDICAL CARE VENOUS LINE 03-95482Cleared 510(K)
- K853555FAST FORMALERT2Cleared 510(K)
- K852135BSM 21 BLOOD SAFETY MODULE2Cleared 510(K)
- K852134BSM 22 BLOOD SAFETY MODULE2Cleared 510(K)
- K844504SARTORIUS MINISART SM 16596HY2Cleared 510(K)
- K844185MODIFIED C-DAK2Cleared 510(K)
- K843531ASN MONITOR SINGLE NEEDLE MONITOR2Cleared 510(K)
- K843632HOLLOW FIBER DIALYZER2Cleared 510(K)
- K840937CAPILLARY FLOW DIALYZERS2Cleared 510(K)
- K840845HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K842436ERIKA NEGATIVE PRESS. ARTERIAL BLOOD2Cleared 510(K)
- K831175FILTRYZER HOLLOW FIBER ARTIF. KIDNEY2Cleared 510(K)
- K831174FILTRYZER HOLLOW FIBER ARTIFICIAL KID-2Cleared 510(K)
- K831176FILTRYZER HOLLOW FIBER ARTIF. KIDNEY2Cleared 510(K)
- K831173TORAY INDUSTRIES FILTRYZER HOLLOW FIBER2Cleared 510(K)
- K840859MAKS CENTRAL DELIVERY SYS-11-200 ETC2Cleared 510(K)
- K840654DIALYSIS ADMIN. SET - I.V.2Cleared 510(K)
- K841124DIALYSIS TRAY2Cleared 510(K)
- K840062BSM 2000 DIALYSIS MACHINE2Cleared 510(K)
- K840146EXP* 700 PARALLEL PLATE DIALYZER2Cleared 510(K)
- K840057EXP* 500 PARALLEL PLATE DIALYZER2Cleared 510(K)
- K834596BLOOD TUBING2Cleared 510(K)
- K833906NEGATIVE PRESSURE VENOUS BLOOD LINE2Cleared 510(K)
- K833905NEGATIVE PRESSURE ARTERIAL BLOOD2Cleared 510(K)
- K833896BICARBOLYTE HEMO-DIAL2Cleared 510(K)
- K833308DUAL LUMEN NEEDLE2Cleared 510(K)
- K833252ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF2Cleared 510(K)
- K833440BLOOD SAFETY MODULE BSM22Cleared 510(K)
- K833503CLIRANS MODEL TAF 15 HOLLOW FIBER2Cleared 510(K)
- K833653D-LYTE2Cleared 510(K)
- K832925MODIFICATION IN MEMBRANE HOUSING CONFI2Cleared 510(K)
- K833150ASAHI HOLLOW FIBER KIDNEYS, EXCEL2Cleared 510(K)
- K832894LUNDIA 10-2-L PARALLEL PLATE HEMODIALY2Cleared 510(K)
- K832666NEPHROSS PRESTO2Cleared 510(K)
- K832623TOP DISPOS. INFUSION SET/HEMODIALY2Cleared 510(K)
- K832053SINGLE PATIENT SYS. II MODEL DM-4502Cleared 510(K)
- K831663TISSUE FORCEPS2Cleared 510(K)
- K832252CLIRANS TAF06 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K832103BLOOD TUBING SET2Cleared 510(K)
- K831770ARTIFICIAL KIDNEY BLOOD CIRCUIT2Cleared 510(K)
- K831409HAEMOLYTE SOLUTION2Cleared 510(K)
- K831606GF-180-L HOLLOW FIBER HEMODIALYSIS2Cleared 510(K)
- K831482CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &2Cleared 510(K)
- K831376CDS 2001 ARTIFICIAL KIDNEY2Cleared 510(K)
- K831433EXTRASENSR ULTRAFILTRATION MONITOR2Cleared 510(K)
- K831338LUNDIA 10-3-L PARALLEL FLOW DIALYZER2Cleared 510(K)
- K830905LUNDIA 10-2-N PARALLEL FLOW DIALYZER2Cleared 510(K)
- K830729C-DAK ARTIFICIAL KIDNEY2Cleared 510(K)
- K830291WAK WEARABLE ARTIFICIAL KIDNEY2Cleared 510(K)
- K823839AMPCO KIDNEY DIALYSIS TRAY2Cleared 510(K)
- K830231ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES2Cleared 510(K)
- K830183ASAHI HOLLOW FIBER KIDNEYS NR SERIES2Cleared 510(K)
- K822339KF-101-13 DIALYZER2Cleared 510(K)
- K822338KF-101-10 DIALYZER2Cleared 510(K)
- K822337KF-101-07 DIALYZER2Cleared 510(K)
- K823715SINGLE ACCESS DEVICE (SSAD)2Cleared 510(K)
- K823068MEDISYSTEMS FISTULA NEEDLES2Cleared 510(K)
- K823069KF-E SERIES HOLLOW FIBER DIALYZER2Cleared 510(K)
- K830021A.V. FISTULA CANNULATION SETS2Cleared 510(K)
- K823733EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR2Cleared 510(K)
- K823826CAPILLARY FLOW DIALYZERS2Cleared 510(K)
- K823791LUNDIA 10-5-L PARRALLE FLOW DIALYZER2Cleared 510(K)
- K823778GAMMA STERILIZED CAPILLARY FLOW DIALYZ2Cleared 510(K)
- K823707HOSPAL BLOOD LINES2Cleared 510(K)
- K823546RENAFLO II2Cleared 510(K)
- K823375NEPHROSS, ANDANTE H.F.2Cleared 510(K)
- K822340EXTRACORPOREAL SINGLE NEEDLE MODULE2Cleared 510(K)
- K822796NEGATIVE PRESSURE ARTERIAL BLOOD LINE2Cleared 510(K)
- K822738TRIEX-IH DIALYZER2Cleared 510(K)
- K822244NEPHROSOL2Cleared 510(K)
- K822283TS-000 ARTERIOVENOUS BLOOD TUBING SET2Cleared 510(K)
- K822225ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE2Cleared 510(K)
- K822226ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN2Cleared 510(K)
- K822049LUNDIA 10-5 N PARALLEL FLOW DIALYZER2Cleared 510(K)
- K821367GF-180-M & GF-180-H HEMODIALYZERS2Cleared 510(K)
- K821495DISPOSABLE BLOOD LINE CONNECTORS2Cleared 510(K)
- K812498CLIRANS TE12 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K811981ISOLATER THP2Cleared 510(K)
- K811977HEMASITE ACCESS MONITOR (TENT.) #RS-82002Cleared 510(K)
- K811457MODEL RS-81002Cleared 510(K)
- K810480SCANLAN SUTURE BOOTS2Cleared 510(K)
- K810074ACCUFLO 1002Cleared 510(K)
- K801354BIONICS ARTERIAL/VENOUS FISTULA NEEDLE2Cleared 510(K)
- K801356BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET2Cleared 510(K)
- K801355BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR2Cleared 510(K)
- K792277MODEL 7620 LINE CLAMP2Cleared 510(K)
- K791411COAXIAL DUAL FLOW CATHETER2Cleared 510(K)
- K790841TG 2, TRI-GARD PRESSURE MONITOR2Cleared 510(K)
- K790591HEMODIALYSIS BLOOD CIRCUIT2Cleared 510(K)
- K790381ARTERIOVENOUS SETS2Cleared 510(K)
- K781050DLC 500, DOUBLE LUMEN CATHETER2Cleared 510(K)
- K771424TUBE OCCLUDING FORCEPS2Cleared 510(K)
- K770691GAMBRO VENOUS BLOOD LINE2Cleared 510(K)
- K770482CATHETER, SINGLE PUNCTURE Y2Cleared 510(K)
- K770552CATHETER, KIDNEY DIALYSIS, HEMO-CATH II2Cleared 510(K)
- K770524TRANSDUCER PROTECTOR, RT-901, RT-9022Cleared 510(K)
- K770475PRESSURE TRANSDUCER ISOLATER CODE 5ML6L22Cleared 510(K)
- K770382NEEDLE, FISTULA, ERIKA2Cleared 510(K)
- K770383STOPCOCK, ONE WAY2Cleared 510(K)
- K770213BARIOR2Cleared 510(K)
- K770044DNC 141 VINCA-FLO2Cleared 510(K)
- K770048DNC 162 VINCA-FLO2Cleared 510(K)
- K770046DNC 142 VINCA-FLO2Cleared 510(K)
- K770045DNC 152 VINCA-FLO2Cleared 510(K)
- K770043DNC 161 VINCA-FLO2Cleared 510(K)
- K760994MONITOR LINE W/FILTER & NEEDLE2Cleared 510(K)
- K761051BI-FLOW NEEDLE2Cleared 510(K)
- K761082SINGLE NEEDLE HEMODIALYSIS (BFC-142)2Cleared 510(K)
- K761081SINGLE NEEDLE HEMODIALYSIS (BFC-161)2Cleared 510(K)
- K761078HEMO-CATH I, KIDNEY DIALYSIS CATHETER2Cleared 510(K)
- K761038SINGLE NEEDLE HEMODIALYSIS2Cleared 510(K)
- K760935WINGED FISTULA NEEDLE2Cleared 510(K)
- K760665FISTULA NEEDLE (#11-265)2Cleared 510(K)
- K760638FILTER, PMF 10002Cleared 510(K)
- K760640FILTER SET, PMF 10242Cleared 510(K)
- K760639FILTER SET, PMF 20282Cleared 510(K)
- K760637FILTER SET, PMF 14482Cleared 510(K)
- K760625FILTER SET PMF 11682Cleared 510(K)
- K760633FILTER SET PMF 10282Cleared 510(K)
- K760632FILTER SET PMF 20242Cleared 510(K)
- K760631FILTER SET 12882Cleared 510(K)
- K760630FILTER SET PMF 2002Cleared 510(K)
- K760629FILTER SET PMF 1002Cleared 510(K)
- K760628FILTER SET PMF 24482Cleared 510(K)
- K760627FILTER SET PMF 21682Cleared 510(K)
- K760626FILTER SET PMF 22882Cleared 510(K)
- K760042BLOOD TUBING SETS2Cleared 510(K)
- 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
- QJNLaparoscopic Accessories, Esophageal Sizing2Product Code
- QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia2Product 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
FAST FORMALERT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K853555
- 510(k) Type
- Traditional
- Applicant
- ORGANON TEKNIKA CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/26/1986
- Days to Decision
- 304 days