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Gastroenterology, Urology

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

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RecordFirmDate
CONSTRICTOR RING FOR PENILE ERECTION (K891125)Performance, Inc.1989-04-27
BARD GASTROSTOMY FEEDING DEVICE (K890870)C.R. Bard, Inc.1989-04-27
BARD MOSS(R) GASTROSTOMY TUBE (K890871)C.R. Bard, Inc.1989-04-27
LUXTEC ACO SERIES 4000 LIGHT SOURCE (K890716)Luxtec Corp.1989-04-26
SUBCLAVIAN HEMODIALYSIS CATHETER (K884322)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-04-25
FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE (K892000)Schott Fiber Optics, Inc.1989-04-25
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M (K892262)Fresenius USA, Inc.1989-04-25
COOK-GIANTURCO BILIARY Z STENT (K882610)Cook, Inc.1989-04-21
SIGMOID TONOMITOR (K890466)Tonometrics, Inc.1989-04-21
BELZER UW-CSS (K883782)Du Pont Critical Care1989-04-20
BICARBONATE CONCENTRATE POWDER (K891921)Haemolyte, Inc.1989-04-17
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER (K890029)Medical Components, Inc.1989-04-17
MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES (K884097)Circon Acmi1989-04-17
CHISELS- FREER, LUCAS, ALEXANDER, BISHOP (K891902)Zinnanti Surgical Instruments, Inc.1989-04-12
MODIFIED VAS-CATH CATHETER REPAIR KIT (K890099)Vas-Cath, Inc.1989-04-11
SODIUM BICARBONATE, U.S.P. (K891159)Williams Medical Co.1989-04-07
DC-4 SHUNT INFUSION T (K891754)Akcess Medical Products, Inc.1989-04-07
FC-101 FEMORAL CATHETER GUIDE WIRE (K891764)Akcess Medical Products, Inc.1989-04-07
DA-46 FLUID BARRIER (K891752)Akcess Medical Products, Inc.1989-04-07
FC-100 FEMORAL CATHETER (K891763)Akcess Medical Products, Inc.1989-04-07
MODIFICATION HEMOFILTRATION CATHETER HF-100 (K890717)Vas-Cath, Inc.1989-04-05
ENTERAL FEEDING TUBE (K890116)Hdc Corp.1989-04-05
PERITONEAL CATHETERS WITH AN ADDED FUNCTION (K890288)Quinton, Inc.1989-03-27
TECHNOMED PULSOLITH LASER SYSTEM (K890436)Teknomed, Inc.1989-03-23
UROLOGICAL LOOP RETRIEVERS (K891252)Northgate Research, Inc.1989-03-22
UROLOGICAL STONE BASKET (K891254)Northgate Research, Inc.1989-03-22
UROLOGICAL GRASPING FORCEPS (K891253)Northgate Research, Inc.1989-03-22
COLONOSCOPE GUIDING TUBE DEVICE (K884857)Mill-Rose Laboratory1989-03-17
TORAY FILTRYZER DIALYZERS (K884339)Toray Industries (America), Inc.1989-03-17
ADMS SILENT NEEDLE GUN (K882746)Advanced Diagnostic Medical Systems, Inc.1989-03-17
HEMOSORBA CH-500, CH-350 AND CH-180 (K885017)Asahi Medical Co., Ltd.1989-03-17
BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 (K885092)Medical Imaging Systems, Inc.1989-03-10
ADMS BIOPSY NEEDLE (K890203)Advanced Diagnostic Medical Systems, Inc.1989-03-08
BIOPSY NEEDLE GUIDE ATTACHMENT (K890327)Elscint, Inc.1989-03-08
CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200 (K884025)Circon Acmi1989-03-03
FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT (K885339)Superior Healthcare Group, Inc.1989-03-01
ZINETICS(R) EMC (K884527)Zinetics Medical, Inc.1989-02-28
MAGLINTE ENTEROCLYSIS CATHETER (K884379)Lafayette Pharmacal, Inc.1989-02-28
EP-100 (SERIES) (K884415)Stereotactic Medical Systems, Inc.1989-02-28
URINARY DRAINAGE UNIT (K890551)Consolidated Products & Services, Inc.1989-02-28
CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) (K890550)Consolidated Products & Services, Inc.1989-02-28
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE (K885169)Boston Scientific Corp1989-02-27
TORAY FILTRYZER BK SERIES (K883407)Toray Industries (America), Inc.1989-02-27
CP&S GAVAGE CONSTAINER, DISPOSABLE (K890552)Consolidated Products & Services, Inc.1989-02-24
O'NEIL URINARY CATHETER INTRODUCER (K884819)Medical Marketing Group1989-02-17
EXPANDABLE BILIARY STENT ENDOPROSTHESIS (K885180)Schneider Intl., Ltd.1989-02-16
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS (K883189)KARL STORZ Endoscopy-America, Inc.1989-02-13
CANDELA STONE BASKETS (K884738)Candela Laser Corp.1989-02-09
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 (K883111)Baxter Healthcare Corp1989-02-08
LAKE N/G FEEDING TUBE (K884127)Lake Medical Products, Inc.1989-02-08
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G (K890315)Baxter Healthcare Corp1989-02-08
INTERA SHIELD AND INTERA UNDERGARMENT (K885185)Intera Corp.1989-02-08
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER (K890111)Gambro, Inc.1989-02-08
DACOMED EXTERNAL MALE CONTINENCE DEVICE (K885323)Dacomed Corp.1989-02-08
SURGITEK (R) UROFLOW SYSTEM (K883274)Medical Engineering Corp.1989-02-08
THE BOOSTER (K860698)Knapps Corp.1989-02-03
MICROVASIVE GOLD PROBE (K885005)Boston Scientific Corp1989-02-01
RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS (K883748)Kawasumi Laboratories Co., Ltd.1989-01-31
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 (K884554)Baxter Healthcare Corp1989-01-31
TRUDELL BENT CATHETER (K885167)Sil-Med Corp.1989-01-31
URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 (K882714)Lsl Industries, Inc.1989-01-31
16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR (K885202)Coeur Laboratories, Inc.1989-01-31
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS (K884725)Baxter Healthcare Corp1989-01-30
DRIPRIDE PROVIDE SLIM (K883894)Weyerhaeuser Co.1989-01-30
DRIPRIDE ULTRA INCONTINENT PAD (K883895)Weyerhaeuser Co.1989-01-30
MICROSURGICAL CYSTOTOME (K890218)Kinetic Medical Products1989-01-27
EURO-COLLINS SOLUTION SETS (K884609)Fresenius USA, Inc.1989-01-26
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER (K884900)Siemens Medical Solutions USA, Inc.1989-01-13
CIRCON ACMI BICAP III THERAPEUTIC SYSTEM (K884254)Circon Acmi1989-01-11
CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20 (K884252)Circon Acmi1989-01-10
BARD(R) ASPIRATION BIOPSY SYSTEM (K883469)C.R. Bard, Inc.1989-01-06
BICAP ABLATING FORCEPS BAF-7 (K884306)Circon Acmi1989-01-05
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE (K884153)Candela Laser Corp.1988-12-28
TRANSLUMINAL ENDARTERECTOMY DEVICE (K884154)Thomas J. Fogarty, M.D.1988-12-27
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT (K884275)Abbott Laboratories1988-12-22
HEMODIALYSIS CONCENTRATES (K883068)Dove Medical Supplies1988-12-22
DOUBLE CLOSED URINARY DRAINAGE SYSTEM (K883886)Knight Medical, Inc.1988-12-19
TRANSENDOSCOPIC ASPIRATION NEEDLE (K883093)Endovations1988-12-08
ODOR-END EMERGENCY CLEAN UP POWDER (K882878)Cdc Products Corp.1988-12-08
BLOOD TUBING SET (K884243)Mediflex Intl.1988-12-08
MULTIFLOW(TM) 60 KIT (K884365)Hospal Medical Corp.1988-12-08
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER (K883592)Impra, Inc.1988-12-08
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT (K884309)Biosearch Medical Products, Inc.1988-12-08
LAKE N/G EXTENSION SET (K884128)Lake Medical Products, Inc.1988-12-08
ULTRX(TM) 850 ARTIFICIAL KIDNEY (K884353)Cd Medical, Inc.1988-12-08
MODIFIED L.J.'S SEX HELPER (K882531)L.J. Fant & Co.1988-12-08
FILTRAL TM 8 HEMODIALYZER (K884326)Hospal Medical Corp.1988-12-05
GASTROSTOMY FEEDING DEVICE (K884439)Southside Biotechnology1988-12-05
PROSTATIC CORE-CUT NEEDLE (K883884)Euro-Med Intl.1988-12-05
HILL NASOGASTRIC TUBE (K883319)Zinetics Medical, Inc.1988-12-05
KIM NASO-INTESTINAL TUBE (K882918)Sheridan Catheter Corp.1988-12-05
ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH (K883763)Acme-Monaco Corp.1988-11-18
BARD(R) URETERAL STENT W/SUTURE (K883561)C.R. Bard, Inc.1988-11-15
OLYMPUS GF-UM3/EU-M3 (K882061)Olympus Corp.1988-11-15
VAS-CATH CATHETER REPAIR KIT (K883768)Vas-Cath, Inc.1988-11-14
REUSABLE ADULT INCONTINENT DIAPER (K883787)Intera Corp.1988-11-07
CAPD DISPOSABLE Y SYSTEM - DY SET (K883393)Medionics International , Ltd.1988-11-03
NATURALYTE MIXER (K883408)National Medical Care, Medical Products Div., Inc.1988-10-31
MEDITRON ENDOLAV MODEL EL-100 (K882048)Xylog Corp.1988-10-31
COMPAT ENTERAL DELIVERY SYSTEM (K882682)Sandoz Nutrition1988-10-28
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