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Gastroenterology, Urology

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

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RecordFirmDate
ANGIOMED HARZMANN DISCS (K855077)Angiomed U.S., Inc.1986-01-21
FRESENIUS HEMODIALYSIS MACHINE A1008 BSM (K855001)Seratronics, Inc.1986-01-21
ASAHI AM SERIES DIALYZERS (K855212)Advocacy International, Ltd.1986-01-21
CENTRAL VEIN CATHETERIZATION TRAY (K852642)Teleflexmedical, Inc.1986-01-16
CONFIDENT ODOR ELIMINATOR (K852471)Hallmark Industries, Inc.1986-01-14
LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE (K853059)Tridak Division of Indicon, Inc.1986-01-10
NIR LAT MALE EXTERNAL CATHETER (K855209)Mali, Inc.1986-01-10
UMS-100 (K853683)Narco Bio-Systems1986-01-10
ACUTE PERITONEAL DIALYSIS CATHETERS (K854966)Thermedics, Inc.1986-01-09
PLUME Y SET (K854951)Hospal Medical Corp.1986-01-08
HEMODIALYSIS CONCENTRATE (K854391)Dana Laboratories1986-01-08
COLOSHIELD KIT (K855121)Deknatel, Inc.1986-01-08
O'NEIL URINARY CATHETER INTRODUCER (K854443)Pennine Medical , Ltd.1986-01-08
GAMBRO LUNDIA PRO 3 & 5 DIALYZER (K853406)Gambro, Inc.1986-01-08
ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 (K854612)Med-West, Inc.1986-01-03
LONG TERM PERITONEAL CATHETER (K854614)Thermadics, Inc.1985-12-19
ZIMMON BILIARY STENT SET (K851962)Wilson-Cook Medical, Inc.1985-12-17
PVL-4.8-200 BALLOON STONE EXTRACTOR (K851954)Wilson-Cook Medical, Inc.1985-12-17
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH (K854479)Nipro Company, Ltd.1985-12-16
HD-SECURA HEMADIALYSIS MACHINE (K854367)Organon Teknika Corp.1985-12-16
HOLLOW FIBER DIALYZER (K854586)Travenol Laboratories, S.A.1985-12-13
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH (K854580)Coloplast A/S1985-12-13
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 (K854309)Gambro, Inc.1985-12-13
CLIRANS TAF HOLLOW FIBER DIALYZER (K854280)Terumo Medical Corp.1985-12-13
FOUR CHANNEL PH PROBE (K853280)Akron City Hospital1985-12-02
1351 UROFLOW AUTO START (K853936)Life-Tech Intl., Inc.1985-12-02
TUBING CLAMP CAT#1000-A (K854512)Rao Medical Devices, Inc.1985-12-02
MODIFIED AM-SERIES DIALYZERS (K854575)Asahi Medical Co., Ltd.1985-12-02
ROTEX SCREW BIOPSY NEEDLE (K854404)Meadox Surgimed, Inc.1985-12-02
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (K854517)Travenol Laboratories, S.A.1985-12-02
DYNAFEED (K854215)Medline Industries, Inc.1985-12-02
DEPEND FITTED BRIEF (K854378)Kimberly-Clark Corp.1985-12-02
VISTA MED-URISTAT (K853892)Vista Med1985-12-02
MEDSURG ULTRASOUND BIOPSY TRAY (K854289)Medsurg Industries, Inc.1985-11-26
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM (K854297)Medsurg Industries, Inc.1985-11-26
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY (K854291)Medsurg Industries, Inc.1985-11-26
ADULT ABSORBENT INCONTINENT BRIEF (K854408)Weyerhaeuser Co.1985-11-19
URINARY DRAINAGE BAG (K854480)The West Co., Inc.1985-11-19
SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO (K853648)Synectics-Dantec1985-11-18
FRESENIUS DISPOSABLE BLOOD LINES (K853851)Seratronics, Inc.1985-11-12
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT (K854084)Organon Teknika Corp.1985-11-08
DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY (K853513)Cd Medical, Inc.1985-11-06
URI-CATH SYSTEM (K852490)Gesco Intl., Inc.1985-11-05
CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI (K853253)Corpak Co.1985-11-05
E-Z-EM GASTRIC LAVAGE CATHETER (K853384)E-Z-Em, Inc.1985-11-05
ASA BLOOD TUBING LINES (K854271)Organon Teknika Corp.1985-11-05
ENDODYNAMICS SIEGEL THERAPUTIC STENT (K853666)E-Z-Em, Inc.1985-11-05
RENALFO HEMOFILTER CAVHD (K854011)Renal Systems, Inc.1985-11-05
88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT (K853353)Superior Healthcare Group, Inc.1985-11-04
UCD URINE SPECIMEN COLLECTOR (K854173)Baker Instructions Corp.1985-11-04
ENDODYNAMIC SIEGEL SPHINCTEROTOME (K853680)E-Z-Em, Inc.1985-11-04
ULTRACLONE 05-100 GUINEA PIG RBC (K854206)Earl-Clay Laboratories, Inc.1985-10-31
ERIKA ARTERIAL LINE 03-9837-0 (K853962)National Medical Care, Medical Products Div., Inc.1985-10-18
KAY PLUS ADULT DIAPER (K853740)Beghin_Say Intl., Inc.1985-10-17
AMERICAN DILATATION SYSTEM (K853274)American Endoscopy, Inc.1985-10-17
COBE REN NEW-D DISPENSING KIT (K853817)Cobe Laboratories, Inc.1985-10-17
E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY (K852535)Tri-Med Specialties, Inc.1985-10-17
LABORIE URODYNAMICS PROCESSOR (K852856)Tridak Division of Indicon, Inc.1985-10-17
COONS GASTROSTICK SYSTEM (K852552)Medi-Tech, Inc.1985-10-17
VELCRO FISTULA PRESSURE CLAMPS (K853536)Cp Medical1985-10-17
BARD-PARKER BILIARY BALLOON CATHETER (K852293)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-04
TRAVENOL CAPD Y SET 5C4354 (K853550)Travenol Laboratories, S.A.1985-10-04
COLORADO MEDICAL MODEL CTM-3000 (K853735)Colorado Medical, Inc.1985-10-04
RIGID ENDOSCOPE (K853514)American Edwards Laboratories1985-10-04
URODYN 1000 (K853119)Dantec Electronics, Inc.1985-10-04
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH (K853530)E-Z-Em, Inc.1985-10-04
DISPOSABLE, STERILE BIOPSY PUNCH (K853104)August C. Stiefel Research Institute, Inc.1985-10-04
FEEDING UNITS & TUBES (K853288)I M, Inc.1985-10-04
THE KENDALL URINARY OUTPUT MONITOR (K852083)The Kendal Co.1985-09-20
DAVOL RETRIEVAL BALLOON CATHETER (K853543)C.R. Bard, Inc.1985-09-20
IDECAP DIALYZER (K852764)Trans-National Trade Development Corp.1985-09-20
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP (K852084)The Kendal Co.1985-09-20
REVIVE SYSTEM (K844445)Revive Systems Corp.1985-09-17
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (K853486)Olympus Corp.1985-09-12
MINIFILTER HEMOFILTER (K853510)Amicon, Inc.1985-09-12
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE (K853207)American Pharmaseal Div. Ahsc1985-09-12
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO (K851242)Cook, Inc.1985-09-11
DIALYZER, CAPILLARY, HOLLOW FIBER (K853591)Organon Teknika Corp.1985-09-11
RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT (K852749)Mesa Medical, Inc.1985-09-10
RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS (K853413)Alcide Corp.1985-09-06
FILTRAL HEMODIALYZER (K852885)Hospal Medical Corp.1985-09-06
URETERAL STENT (K852389)American Medical Systems, Inc.1985-09-05
ENTERAL FEEDING BAG, 1000 ML, & TUBING SET (K851975)Venusa , Ltd.1985-09-05
DIMENSION TOTAL HIP PROSTHESIS (K853333)Kirschner Medical Corp.1985-09-03
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS (K852951)Welch Allyn, Inc.1985-08-27
URI-SURE (K852619)Ashai Co. , Ltd.1985-08-27
H-H SEXTON SCUP URINE MGMT. SYS (K853458)Holter-Hausner Intl.1985-08-27
P.A. ENTERAL FEEDING BAG 1100 (K853309)Pa Medical Corp.1985-08-27
ENTERAL FEEDING CONTAINER (K852966)Empire Industries, Inc.1985-08-27
TROCAR/CANNULA/SHEATH SET (K853337)American Edwards Laboratories1985-08-23
MIC JEJUNAL FEEDING TUBE (K853197)Medical Innovations Corp.1985-08-22
VACCESS TM 4006 (K853283)Vas-Cath of Canada , Ltd.1985-08-22
EXTERNAL MALE CATHETER (K852051)Buffalo Medical Specialties Mfg., Inc.1985-08-22
OLYMPUS RIGID URETERORENOSCOPE (K852888)Olympus Corp.1985-08-21
URETERAL DILATOR (K852324)American Edwards Laboratories1985-08-21
5F ELECTRODE(LITHOTRIPTOR) (K852874)Northgate Research, Inc.1985-08-21
GASTRO-ENTEROSTOMY TUBE (K852707)Medical Innovations Corp.1985-08-14
MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT (K852363)Medical Innovations Corp.1985-08-09
RADI-BIOPSY DEVICE (K850605)Radiplast AB1985-08-09
URETERAL DILATOR/SHEATH SET (K852793)American Edwards Laboratories1985-08-09
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