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
- K190459Hemoflow F3 and F4 Dialyzers2Cleared 510(K)
- K122952NIPRO PUREFLUX-L HEMODIALYZER2Cleared 510(K)
- K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR2Cleared 510(K)
- K010366DISPOSABLE STORAGE CAP2Cleared 510(K)
- K011148ULTRACONCENTRATOR SYSTEM2Cleared 510(K)
- K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS2Cleared 510(K)
- K991908IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K992594A-15 HEMODIALYZER2Cleared 510(K)
- K992565A-18 HEMODIALYZER2Cleared 510(K)
- K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X2Cleared 510(K)
- K990159DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 901112Cleared 510(K)
- K982337CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER2Cleared 510(K)
- K981253ULTRACON ULTRAFILTRATOR2Cleared 510(K)
- K980658PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M42342Cleared 510(K)
- K971710ULTRACON ULTRAFILTRATOR2Cleared 510(K)
- K973291DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES2Cleared 510(K)
- K970708CLIRANS T-SERIES HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K963933PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K962309ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS2Cleared 510(K)
- K961039BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL2Cleared 510(K)
- K961040BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC2Cleared 510(K)
- K961026BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL2Cleared 510(K)
- K944436COBE CENTRYSYSTEM CS 200 DIALYZER2Cleared 510(K)
- K952343FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER2Cleared 510(K)
- K950602PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS2Cleared 510(K)
- K945746GAMBRO LUNDIA 94-500 DIALYZER2Cleared 510(K)
- K945622MCA(TM) 180 HEMODIALYZER2Cleared 510(K)
- K935471FILTRYZER(TM)2Cleared 510(K)
- K945631155 SCE(TM) HEMODIALYZER2Cleared 510(K)
- K945624MCA(TM) 160 HEMODIALYZER2Cleared 510(K)
- K945623MCA(TM) 130 HEMODIALYZER2Cleared 510(K)
- K941708COBE CENTRYSYSTEM CS500 DIALYZER2Cleared 510(K)
- K940910FILTRYZER2Cleared 510(K)
- K950454CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER2Cleared 510(K)
- K930503CLIRANS WET PACK HOLLOW FIBER DIALYZER2Cleared 510(K)
- K926372MCA 200 HEMPDIALYZER2Cleared 510(K)
- K926567BAXTER CA DIALYZER2Cleared 510(K)
- K926005FRESENIUS HEMOFLOW, VARIOUS MODELS2Cleared 510(K)
- K914790HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R2Cleared 510(K)
- K905779ALDETECT2Cleared 510(K)
- K904566NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER2Cleared 510(K)
- K905228MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ2Cleared 510(K)
- K903567BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.2Cleared 510(K)
- K902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER2Cleared 510(K)
- K893677HOLLOW FIBER DIALYZER FOCUS 70H2Cleared 510(K)
- K891477CLIRANS HOLLOW FIBER HEMODIALYZER (WET)2Cleared 510(K)
- K892375MODIFIED AM-SERIES DIALYZERS2Cleared 510(K)
- K892374NEW AM-SERIES DIALYZERS2Cleared 510(K)
- K892523GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY2Cleared 510(K)
- K884339TORAY FILTRYZER DIALYZERS2Cleared 510(K)
- K890111GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K883748RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K883644CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 1702Cleared 510(K)
- K883534CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.1002Cleared 510(K)
- K883589GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K881811COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K882158MODIFIED TORAY FILTRYZER DIALYZERS2Cleared 510(K)
- K882680ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA2Cleared 510(K)
- K882339BIO*NEPHROSS I.Q. ANDANTE2Cleared 510(K)
- K882215NEPHROSS I.Q. MODERATO2Cleared 510(K)
- K882213NEPHROSS I.Q. ALLEGO2Cleared 510(K)
- K880084GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K874872FRESENIUS HEMOFLOW F3, F4, F5, F72Cleared 510(K)
- K874728CAPILLARY FLOW DIALYZERS2Cleared 510(K)
- K874549NEPHROSS I.Q. ANDANTE2Cleared 510(K)
- K880083GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K871471CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-152Cleared 510(K)
- K871236HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H2Cleared 510(K)
- K870725FRESENIUS HEMOFLOW F6 AND F82Cleared 510(K)
- K870169CAPILLARY FLOW DIALYZERS2Cleared 510(K)
- K864831COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS2Cleared 510(K)
- K863044CAPILLARY FLOW HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K863592DISSCAP 80E, 110E, 140E, 160E2Cleared 510(K)
- K862693TORAY FILTRYZER DIALYZER, B1-2.0.2Cleared 510(K)
- K861916ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER2Cleared 510(K)
- K861537ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-52Cleared 510(K)
- K861536ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-72Cleared 510(K)
- K855212ASAHI AM SERIES DIALYZERS2Cleared 510(K)
- K854280CLIRANS TAF HOLLOW FIBER DIALYZER2Cleared 510(K)
- K854575MODIFIED AM-SERIES DIALYZERS2Cleared 510(K)
- K853591DIALYZER, CAPILLARY, HOLLOW FIBER2Cleared 510(K)
- K851380DISSCAP 110 DIALYZER2Cleared 510(K)
- K850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-2Cleared 510(K)
- K850655TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B22Cleared 510(K)
- K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID2Cleared 510(K)
- K820524CLIRANS HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K821587ERIKA HPF 50 DIALYZER2Cleared 510(K)
- K820743HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K821690ERIKA HPF 100,200,300 DIALYZER2Cleared 510(K)
- K820304GAMBRO GF-80-M, GF-80-H HEMODIALYZER2Cleared 510(K)
- K812353KF-E SERIES OF HOLLOW FIBER DIALYZERS2Cleared 510(K)
- K802894CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY2Cleared 510(K)
- K802893CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY2Cleared 510(K)
- K802613C-PAK MODEL 12 ARTIFICIAL KIDNEY2Cleared 510(K)
- K802441CLIRANS TH10 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K802122CLIRANS TH13 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K802114NEPHROSS DIALYZER2Cleared 510(K)
- K802092HF-100 DIALYZER2Cleared 510(K)
- K802466DISSCAP HOLLOW FIBER DIALYZER2Cleared 510(K)
- K801559HOLLO FIBER DIALYZER2Cleared 510(K)
- K801825RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.2Cleared 510(K)
- K801826RENAFLO HOLLOW FIBER DIALYZERS #MP 1402Cleared 510(K)
- K801827RENAFLO HOLLOW FIBER DIALYZER #100.12Cleared 510(K)
- K801192CLIRANS TE10 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K801194CLIRANS TE07 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K801178COBE HF80, CAT. #18-5802Cleared 510(K)
- K801370GF-120-L DIALYZER2Cleared 510(K)
- K801344EXTRACORPOREALS' ALTERNATE MEMBRANE2Cleared 510(K)
- K801045GF120H DIALYZER2Cleared 510(K)
- K800704C-DAK TM 2800 ARTIFICIAL KIDNEY2Cleared 510(K)
- K800336GAMBRO LUNDIA FIBER2Cleared 510(K)
- K800549MODEL TRIEX-L HOLLOW FIBER DIALYZER2Cleared 510(K)
- K800270TRIEX-2 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K800221CF/211 CAPILLARY FLOW DIALYZER, #5M17842Cleared 510(K)
- K792419C-DAK 2100 ARTIFICIAL KIDNEY2Cleared 510(K)
- K791320ERIKA HPF 1002Cleared 510(K)
- K791322ERIKA HPF 3002Cleared 510(K)
- K791321ERIKA HPF 2002Cleared 510(K)
- K790696RDI-1 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K790308DISPOSABLE DIALYZERS, SD-ID, SD-2D2Cleared 510(K)
- K790067FLOW DIALYZER, CF 2300 CAPILLARY2Cleared 510(K)
- K782151ARTIFICIAL KIDNEY, C-DAK 0.6D2Cleared 510(K)
- K781142DISSCAP2Cleared 510(K)
- K781058C-DAK 4000 ARTIFICIAL KIDNEY2Cleared 510(K)
- K772290DIALYZER, CAPILATORY, HOLLOW FIBER2Cleared 510(K)
- K772423SPIRAFLOW DIALYZERS2Cleared 510(K)
- K771694CLIRANS TH 15 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K770867DIALYZER, FIBER, HOLLOW2Cleared 510(K)
- K770734DIALYZER, FIBER, HOLLOW2Cleared 510(K)
- K761007ARTIFICIAL KIDNEY, C-DAK CORDIS DOW2Cleared 510(K)
- K760252DIALYZER, HF 130 HOLLOW FIBER2Cleared 510(K)
- 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
- 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
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K820304
- 510(k) Type
- Traditional
- Applicant
- GAMBRO, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/2/1982
- Days to Decision
- 26 days