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Gastroenterology, Urology

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

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RecordFirmDate
GAMBRO WATER PURIFICATION MONITOR WRD (K811678)Gambro, Inc.1981-07-10
DENVER PERITONEO-VENOUS SHUNT (K811183)Denver Biomedicals, Inc.1981-07-01
SUCTION WOUND DRAINAGE DEVICE (K810739)The Urology Group1981-06-26
FORDER RETRACTOR (K811693)Dacomed Corp.1981-06-26
ETHIX FEEDING TUBES POLYURETHANE/RADIOP. (K811639)Ethox Corp.1981-06-26
GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET (K811580)Porges Catheter Corp.1981-06-26
MODEL RS-8100 (K811457)Rinal Systems, Inc.1981-06-23
MODEL DM-333 DIALYSIS CONTROL STATION (K811444)Extracorporeal Medical Specialities, Inc.1981-06-23
MODEL FUS-1, FLEXIBLE URETEROSCOPE (K811535)American Optical Corp.1981-06-23
AUTOMATED GASTRIC LAVAGE (K811061)Emergency Medicine1981-06-23
QUINTON CATHETER FINGER GRIP (K811266)Quinton, Inc.1981-06-18
CHEMATIC BICARBONATE DIALYSATE SYSTEM (K810605)Trimedyne, Inc.1981-06-16
SUR-FIT LOOP OSTOMY O.R. SET (K811240)E. R. Squibb & Sons, Inc.1981-06-16
EXP 200 PARALLEL PLATE DIALYZER (K811439)Extracorporeal Medical Specialities, Inc.1981-06-12
MMG URINARY DRAINAGE TUBING (K811469)Medical Marketing Group1981-06-12
EXP 600 PARALLEL PLATE DIALYZER (K811440)Extracorporeal Medical Specialities, Inc.1981-06-12
GAMBRO PERITONEAL DIALYSIS FLUID LINES (K811294)Gambro, Inc.1981-06-12
COBE PPD .8 (K810066)Cobe Laboratories, Inc.1981-06-09
ECONOMY OPEN END DRAINAGE BAG (K811300)Economy Plus1981-06-09
SUR-FIT DISPOSABLE CONVEX INSERT (K811239)E. R. Squibb & Sons, Inc.1981-06-09
VANCE PROSTATIC ASPIRATION SET (K811454)Vance Products, Inc.1981-06-09
PARALLEL PLATE DIALYZER HOLDER (K811292)Extracorporeal Medical Specialities, Inc.1981-06-02
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT (K810979)Arrow Intl., Inc.1981-06-02
SUR-FIT IRRIGATION SLEEVE (K811160)E. R. Squibb & Sons, Inc.1981-06-02
FORMULATION CHANGE IN UNITED SKIN BARR (K810726)Howmedica Corp.1981-06-02
VASOVASOSTOMY STABILIZER PLATFORM DEV (K811223)Biomet, Inc.1981-05-21
SUR-FIT DISPOSABLE FANGE CAP (K811163)E. R. Squibb & Sons, Inc.1981-05-21
THE SCOTT DIALMENZENSERT (K810915)Lone Star Medical Products, Inc.1981-05-08
LIXIVITRON (K802828)United Medical1981-05-08
CAPD CATHETER ADAPTER (K810683)American Mcgaw1981-05-08
CYBER 80 HEMODIALYZER (K810837)Cyberex Corp.1981-05-05
SELECT-A-FLOW COLLECTOR (K810645)Wenmar Intl. Corp.1981-05-05
PORTADIAL CARRY-ON KIDNEY MACHINE (K802297)Alan P. Kendal, Ph.D.1981-05-01
HEMOPHRON (K810612)Renal Devices, Inc.1981-04-29
AMP PERITONEAL DIALYSIS PREP KIT (K810840)American Medical Products, Inc.1981-04-29
ENTERNAL PUMP SET W/INTEGRAL CONTAINER (K810996)Abbott Laboratories1981-04-29
TUBE FEEDING SET (K810573)Harvard Laboratories1981-04-23
NATURALYTE BICARBONATE DIALYSATE CONCEN. (K810925)Erika, Inc.1981-04-23
CHEM-DIALYTE CONCENTRATES (K810527)Luchem Pharmaceuticals, Inc.1981-04-23
CURITY 100% SILICONE SAFETY INDICATOR (K810690)The Kendal Co.1981-04-23
KANGAROO NASOGASTRIC FEEDING TUBE (K810854)Chesebrough-Pond'S U.S.A. Co.1981-04-17
ERIKA HEPARIN INFUSION ADAPTOR (K810824)Erika, Inc.1981-04-17
DRAINING-WOUND MGMT. SYSTEM (K810812)Johnson & Johnson Professionals, Inc.1981-04-17
ERIKA EXTENSION SETS (K810823)Erika, Inc.1981-04-17
I.V. ADMINISTRATION SET (K810757)American Mcgaw1981-04-08
KEY-MED FIBRESCOPE DISINFECTION TROLLEY (K810818)Keymed, Inc.1981-04-08
HOLLISEAL OSTOMY SKIN BARRIER (K810807)Hollister, Inc.1981-04-07
TRAY, CATHERIZATION, URETHRAL (K810249)Megaplast, Inc.1981-04-07
PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT (K810506)Propper Mfg. Co., Inc.1981-04-07
HOLLISTER SKIN BARRIER B (K810710)Hollister, Inc.1981-04-07
HOLLISTER SKIN BARRIER A (K810709)Hollister, Inc.1981-04-07
TRAY, IRRIGATION (K810250)Megaplast, Inc.1981-04-07
FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE (K810503)Olympus Corp.1981-04-03
PENTAX COLONOSCOPE MODEL FC-34LA (K810682)Pentax Precision Instrument Corp.1981-04-03
DOUBLE LUMEN SUBCLAVIN CATHETER SC-400 (K810745)Vas-Cath of Canada , Ltd.1981-03-31
SILICONE ELASTOMER COATED LATEX FOLEY (K810630)G.D. Searle and Co.1981-03-31
OESOPHAGEAL THERAPY KIT (K810392)Keymed, Inc.1981-03-31
UROLOGIC TUBE HOLDER (K810787)The Urology Group1981-03-31
PENTAX COLONOSCOPE MODEL FC-34 MA (K810791)Pentax Precision Instrument Corp.1981-03-31
STOPPERLESS HOT/COLD RUBBER WATER BOTTLE (K810654)First Industries, Inc.1981-03-27
VASCULAR ACCESS SYSTEM (K810114)Bentley Laboratories, Inc.1981-03-26
CCPD 3 LITER DRAINAGE SET (K810671)American Medical Products, Inc.1981-03-24
CCPD CYCLER SET (K810670)American Medical Products, Inc.1981-03-24
CAPD EXCHANGE SET (K810600)American Mcgaw1981-03-24
ALTERNATE STERILIZ. FOR CELLULOSE ACET (K810315)Cordis Corp.1981-03-20
VANCE URETHAL DILATOR SET (K810371)Vance Products, Inc.1981-03-20
VANCE DEFLECTABLE BIOPSY BRUSH SET (K810372)Vance Products, Inc.1981-03-20
VANCE PERCUTANEOUS MALECOT NEPHROSTOMY (K810368)Vance Products, Inc.1981-03-20
POLLACK CHAIN CYSOURETHROGRAM SET (K810370)Vance Products, Inc.1981-03-20
KISH URETHRAL ILLUMINATED CATHETER SET (K810367)Vance Products, Inc.1981-03-20
POLYPECTOMY SNARE (K810336)Medi-Tech, Inc.1981-03-20
CYBER 120 HEMODIALYZER (K802478)Cyberex Corp.1981-03-20
VESSEL TIPS, SIZES 13-18 (K810257)Quinton, Inc.1981-03-13
MIROMED PERITONEAL DIALYSIS CATHETER (K810236)American Medical Products, Inc.1981-03-13
KPP PERITONEAL DIALYSATE FILTER (K803275)Millipore Corp.1981-03-13
CURITY 100% SILICONE IRRIGATION FOLEY (K810691)The Kendal Co.1981-03-13
SCANLAN SUTURE BOOTS (K810480)Scanlan Intl., Inc.1981-03-13
INCONTINENT PAD & BELT (K810544)Principle Business Ent.1981-03-11
CIRCLE NEPHROSTOMY TUBE INTRODUCER (K810533)American V. Mueller1981-03-11
PERCUTANEOUS GASTROINTESTINAL TUBE (K810499)Health Development Corp.1981-03-04
ACCUFLO 100 (K810074)Renal Care Corp.1981-03-04
NIKKISO ND-14 PARALLEL FLOW DIALYZER (K803068)NIKKISO CO., LTD.1981-03-04
ARGYLE SALEM SUMP TUBE (K810156)Sherwood Medical Co.1981-03-02
ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST. (K810393)Keymed, Inc.1981-03-02
ADMINISTRATION SET (K810131)G.D. Searle and Co.1981-02-26
GAMBRO BICARBONATE MODULE, BCM-10 (K810127)Gambro, Inc.1981-02-25
UROLOGICAL CATHETERS (K810281)Latex Ind., Inc.1981-02-25
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (K810280)Cobe Laboratories, Inc.1981-02-19
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY (K802894)Cordis Corp.1981-02-19
MODEL #53110 DISPOSABLE ANOSCOPE (K810227)Welch Allyn, Inc.1981-02-19
CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY (K802893)Cordis Corp.1981-02-13
WILLIAMS OESOPHAGEAL VARICES INJECT TUBE (K810180)Keymed, Inc.1981-02-09
ARGYLE ROB-NELS (K810216)Sherwood Medical Co.1981-02-09
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE (K802364)Extracorporeal Medical Specialities, Inc.1981-01-29
INPERSOL CAPD BAG PORT CLAMP (K803300)Abbott Laboratories1981-01-29
ERECTAID (K803111)Burditt & Calkins-Siemens-Elema1981-01-23
FLO-TEMP (K810021)Laminar Flow Industries1981-01-23
DIALYIS START CARE KIT (K802361)Med-Pak Corp.1981-01-16
CORDIS HAKIM ASCITES VALVE SYSTEM (K803258)Cordis Corp.1981-01-15
ACMI BIPOLAR HEMOSTATIC ELECTRODE (K803214)American Cystocope Makers, Inc.1981-01-15
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