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Gastroenterology, Urology

11,291 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BSM 2000 DIALYSIS MACHINE (K840062)Organon Teknika Corp.1984-03-22
SECURE W/35MM DIAM, SHEATH/ADHESIVE (K840704)Warne Surgical Products, Ltd.1984-03-22
SECURE W/30MM DIAM, SHEATH & ADHESIVE (K840703)Warne Surgical Products, Ltd.1984-03-22
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (K834191)Imm Enterprises , Ltd.1984-03-22
SECURE W/25MM DIAM. SHEATH & ADHESIVE (K840702)Warne Surgical Products, Ltd.1984-03-22
SERENITY CONTOURED ABSORBENT SHIELDS (K840679)Johnson & Johnson Consumer Products, Inc.1984-03-22
NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT (K840936)Biosearch Medical Products, Inc.1984-03-22
BILIARY INDWELLING STENT (K834351)Hobbs Medical, Inc.1984-03-22
URETERAL DOUBLE PIGTAIL STENT (K834401)Hobbs Medical, Inc.1984-03-22
JAKOBI SURG. INSTRUMENTS #3 21/22/24 (K834192)Imm Enterprises , Ltd.1984-03-22
PROBES, VARIOUS (K841003)Premier Dental Products Co.1984-03-20
URETHRAL CATH. TRAY W/BAG (K840292)Corpak Co.1984-03-16
MONOJECT SOFT TISSUE BIOPSY NEEDLE (K834249)Sherwood Medical Co.1984-03-12
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE (K840354)Sherwood Medical Co.1984-03-12
WESTERMAN-JENSEN BIOPSY NEEDLE (K840168)Popper & Sons, Inc.1984-03-12
MILLEREISEN CURVED BIOPSY NEEDLE (K840157)Preventive Medicine Institute1984-03-12
FOLEY CATHETERIZATION TRAY-VARIOUS (K832363)Inmed Corp.1984-03-07
ABSORBENT INCONTINENT PADS & BRIEFS (K834359)Weyerhaeuser Co.1984-03-05
HEMOCATH REPAIR KIT (K840424)Quinton, Inc.1984-03-05
DISPOS. ENTERIC FEEDING TUBES W/SAFE-T (K833687)Superior Plastic Products Corp.1984-03-02
HEMASITE ACCESSORIES MODIFICATION (K840437)Renal Systems, Inc.1984-02-21
EXTENDED LIFE CAPD SOLUTION TRANSFER (K840224)Travenol Laboratories, S.A.1984-02-21
SANDMILL RMS (K834512)Sandhill Scientific, Inc.1984-02-21
PROFILE URODYNAMIC MONITORING SYS (K834503)Browne Medical, Inc.1984-02-21
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (K840436)Renal Systems, Inc.1984-02-21
FLEXIBLE LIQUID LIGHT GUIDE (K834487)Endo Lase, Inc.1984-02-21
MALE INSERT SLIP (K840482)Beghin_Say Intl., Inc.1984-02-21
LAS-2 ALIGNMENT SYSTEM (K834538)Therados, Inc.1984-02-21
ENTERNAL FEEDING TUBE (K834562)Sheridan Catheter Corp.1984-02-13
ETHOX WEIGHTED FEEDING TUBE (K834554)Ethox Corp.1984-02-10
URIHESIVE SYSTEM - IMPROVED (K834337)Convatec, A Division of E.R. Squibb & Sons1984-02-10
K-TUBE REPAIR KIT (K840019)Midwest Metabolic Support Group1984-02-10
URINARY DRAINAGE CONTAINER (K834448)Vital Metrics, Inc.1984-02-10
CAPD PREP KIT (K833780)Professional Dialysis Products1984-02-09
ERCP CANNULA (K834414)Hobbs Medical, Inc.1984-02-04
BIOSPAL (R) 1800S (K834589)Hospal Medical Corp.1984-02-04
FEEDING GASTROSTOMY TUBE (K832093)Tri-Med, Inc.1984-02-04
ESKA JONAS SILICON-SILVER PENILE (K834504)Dacomed Corp.1984-02-04
ADULT INCONTINENCE BRIEF (K834296)Procter & Gamble Mfg. Co.1984-02-04
TEMPERATURE SENSING FOLEY CATHETER (K834438)C.R. Bard, Inc.1984-02-04
ISLAMI GASTROINTESTINAL TUBE (K834268)Biosearch Medical Products, Inc.1984-02-04
INJECTION NEEDLE (K834403)Bobbs Medical, Inc.1984-02-04
TWO CHANNEL GASTROFIBERSCOPE FG-36T (K833924)Pentax Precision Instrument Corp.1984-02-04
HODGE DECOMPRESSION TUBE (K834258)Inmed Corp.1984-02-04
BLOOD TUBING (K834596)Renal Systems, Inc.1984-02-04
COAXIAL BALLOON GASTROESOPHAGEAL DILA (K834451)Thomas J. Fogarty, M.D.1984-02-04
HEMOFILTRATION SYSTEM (K831784)Gambro, Inc.1984-02-04
SILITEK URINARY DIVERSION STENT (K840059)Surgitek1984-02-04
EXP* 700 PARALLEL PLATE DIALYZER (K840146)Extracorporeal Medical Specialities, Inc.1984-02-04
BARD KARAYA GUM WASHERS (K834575)C.R. Bard, Inc.1984-02-04
SUR-FIT UROSTOMY POUCH W/ACCUSEAL (K840166)Convatec, A Division of E.R. Squibb & Sons1984-02-04
UROMETER (K833043)Browne Medical, Inc.1984-02-04
RENAFLO AVF SET FOR HEMODIALYSIS (K834510)Renal Systems, Inc.1984-02-04
GASTROINTESTINAL SHEATH BRUSH (K834402)Hobbs Medical, Inc.1984-02-04
EXP* 500 PARALLEL PLATE DIALYZER (K840057)Extracorporeal Medical Specialities, Inc.1984-02-04
ADULT INCONTINENCE PAD (K834295)Procter & Gamble Mfg. Co.1984-02-04
SUPERIOR ENTERNAL FEEDING SYSTEM (K833947)Superior Plastic Products Corp.1984-02-04
COMFEEL PASTE (K833565)Coloplast A/S1984-01-30
COLOPLAST BABY URINE COLLECTORS (K833570)Coloplast A/S1984-01-30
STERILE DRAINAGE SYSTEM (K833571)Coloplast A/S1984-01-30
PREPACELL THIN NEEDLE ASPIRATION TRAY (K833719)Applied Medical Devices, Inc.1984-01-25
UMI PERCUTANEOUS TRANSHEPATIC CHOLAN (K833937)Universal Medical Instrument Corp.1984-01-03
NEGATIVE PRESSURE VENOUS BLOOD LINE (K833906)Erika, Inc.1984-01-03
BICARBOLYTE HEMO-DIAL (K833896)Edlaw Pharmaceuticals, Inc.1984-01-03
PLASTIC LEG BAG (K831530)Forever-Dry, Inc.1984-01-03
ULTRAFILTRATION CONTROLLER (K832547)Extracorporeal Medical Specialities, Inc.1984-01-03
SHUFFIELD TECH ENEMA TIP (K832960)Shuffield Tech Co.1984-01-03
TAMPONADE BALLOON CUFF (K833859)American Endoscopy, Inc.1984-01-03
NEGATIVE PRESSURE ARTERIAL BLOOD (K833905)Erika, Inc.1984-01-03
CATHETER INSERTION KIT (K833432)Clinipad Corp.1983-12-28
DUAL LUMEN NEEDLE (K833308)Quinton, Inc.1983-12-27
SUCTION-HEMORRHOID-LIGATOR (K832192)Research Endoscope Systems Intl.1983-12-27
COMFEEL CLEANSER (K833566)Coloplast A/S1983-12-27
COMFEEL BARRIER CREAM (K833569)Coloplast A/S1983-12-27
PERITONEAL CATHETER-CHANGES- (K833749)Quinton, Inc.1983-12-27
KELLY CHOLANGIOCATH (K833920)Perry, Div.1983-12-27
MALE THERAPEUTIC POTENT AID (K832543)Mace'S Scientific1983-12-27
TUCK-TITE COLON FLUID RETAINER (K833860)Clayton Medical Products, Inc.1983-12-27
CURITY 100% SILICONE COUDE' CATHETER (K833790)The Kendal Co.1983-12-27
ACUTE HEMODIALYSIS TRAYS (K833139)Intermed, Inc.1983-12-22
ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF (K833252)Erika, Inc.1983-12-14
CLIRANS MODEL TAF 15 HOLLOW FIBER (K833503)Terumo Medical Corp.1983-12-08
BLOOD SAFETY MODULE BSM2 (K833440)Hospal Medical Corp.1983-12-08
P-S MEDICAL BERLIN VISADUCT KIT (K832677)Pudenz-Schulte Medical Research Corp.1983-12-08
DUAL LUMEN SUBCLAVIAN CANNULA (K833848)Shiley, Inc.1983-12-08
PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (K833492)American Endoscopy, Inc.1983-11-29
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE (K833595)Travenol Laboratories, S.A.1983-11-29
HOBBS MEDICAL RETRIEVAL BASKET (K833124)Hobbs Medical, Inc.1983-11-29
RENALLOY HEMASITE VASCULAR ACCESS SHUNT (K833622)Renal Systems, Inc.1983-11-29
FEEDING TUBE (K833591)Medovations, Inc.1983-11-28
ENTRI FLEX FEEDING TUBE (K833621)Biosearch Medical Products, Inc.1983-11-28
D-LYTE (K833653)Dialysis Products, Inc.1983-11-28
AUTOMATIC PERITONEAL DIALYSIS CYCLER (K833065)Travenol Laboratories, S.A.1983-11-28
COAXIAL ELECTRODE #300A (K832566)K-Med, Inc.1983-11-28
PRI A PUS (K832756)Trans Texas Medical Devices Corp.1983-11-28
HYDROFLOW SUCTION IRRIGATION SYSTEM (K833189)Portex, Inc.1983-11-28
ENDOSCOPIC RETROGRADE (K833417)Microvasive1983-11-28
NEEDLE CATHETER JEJUNOSTOMY KIT (K833513)Biosearch Medical Products, Inc.1983-11-28
ACTIVE LIFE (K833625)Convatec, A Division of E.R. Squibb & Sons1983-11-28
MODIFICATION IN MEMBRANE HOUSING CONFI (K832925)Ries Biologicals1983-11-28
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