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Gastroenterology, Urology

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

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RecordFirmDate
GUIDE WIRE (K874164)Endovations1987-12-07
URETHAL CATHETER (K874309)Medovations, Inc.1987-12-07
ENTERAL FEEDING TUBE (K874393)Wilson-Cook Medical, Inc.1987-12-07
'CATCH-IT' OR FECAL CONTAINMENT DEVICE (K873929)Midwest Medical Co.1987-12-03
PHARMASEAL RUBBER URETHRAL CATHETER (K874517)American Pharmaseal Div. Ahsc1987-12-03
PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (K874045)American Pharmaseal Div. Ahsc1987-12-03
CUMEVAC (K874410)Cumes-Honikman Partnership1987-12-03
MSS ENTERAL DELIVERY SET (K872921)Medical Support, Inc.1987-12-03
OLYMPUS LUS ULTRASONIC LITHOTRIPTER (K873367)Olympus Corp.1987-11-30
CLOSED FOLEY CATHETER SYSTEM (K873288)Todd Medical, Inc.1987-11-27
DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (K872006)Mac Lee Medical Products1987-11-17
IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) (K873287)Todd Medical, Inc.1987-11-13
BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE (K873441)Bissell Medical Products, Inc.1987-10-27
GAMBRO BICART SYSTEM (K873155)Gambro, Inc.1987-10-26
ADR-22 AUTOMATIC DIALYZER REPROCESSOR (K874034)Biodynamics Corp.1987-10-23
8810 PUMP-PUMP SINGLE NEEDLE DEVICE (K873279)Cd Medical, Inc.1987-10-23
HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES (K873487)Water Pure, Inc.1987-10-23
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (K873984)Travenol Laboratories, S.A.1987-10-20
PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. (K871922)Chemfet Corp.1987-10-20
SECURLINE FRANSEENE NEEDLE (K873369)Precision Dynamics Corp.1987-10-20
GENERAL PURPOSE COMBINATION PH ELECTRODE (K871921)Chemfet Corp.1987-10-20
STOMACH EVACULATOR - EWALD STYLE (K864963)Medovations, Inc.1987-10-14
MODIFIED RECTAL NOZZLE (K873948)Colon Therapeutics1987-10-14
P. URINE METER, 250CC (K872824)Ni-Med, Inc.1987-10-14
DEVINE (SUPRAPUBIC SOUND AND GUIDE) (K873177)Penn Medical Devices, Inc.1987-10-14
HUFFMAN BIOPSY UNIT (K873176)Penn Medical Devices, Inc.1987-10-14
HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (K872364)Travenol Laboratories, S.A.1987-10-13
ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (K871526)Cox Family Laboratories, Inc.1987-10-13
DIALY-NATE SET & DIALY-NATE CATHETER (K872221)Gesco Intl., Inc.1987-10-13
KAWASUMI A.V. FISTULA SET (K873421)Kawasumi Laboratories Co., Ltd.1987-10-09
LOW PROFILE GASTROSTOMY (K872771)Microvasive1987-10-09
KAWASUMI BLOOD TUBING LINE (K873516)Kawasumi Laboratories Co., Ltd.1987-10-05
LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET (K873435)Level 1 Technologies, Inc.1987-10-05
HOSPAL DIALYSATE FOR C.A.V.H.D. (K872857)Delmed, Inc.1987-10-05
URETERAL BULB DILATORS (K873178)Penn Medical Devices, Inc.1987-09-30
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (K872652)Travenol Laboratories, S.A.1987-09-30
LINDEN STONE EXTRACTION BALLOON (K872509)Hobbs Medical, Inc.1987-09-22
AN3200 DOUBILET DRAIN (K872458)H.W. Andersen Products, Inc.1987-09-21
DURAPHASE PENILE PROSTHESIS (K871653)Dacomed Corp.1987-09-18
SPS SUSPENSION ENEMA KIT (K872992)Carolina Medical Products Co.1987-09-17
SURGITEK INFUSION STENT SYSTEM* (K872353)Surgitek1987-09-16
MOSS(R) MARK IV NASAL TUBES CAT.# 87168 (K872932)Mfg. and Research, Inc.1987-09-15
HEMOCOR PLUS HEMOCONCENTRATOR (K872456)Minntech Corp.1987-09-15
S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS (K873455)Dravon Medical, Inc.1987-09-14
FLEXIBLE URETEROSCOPE (K872282)Intramed Laboratories, Inc.1987-09-14
MMG CATH-N-PLACE (K873136)Medical Technologies of Georgia1987-09-09
MIC MUSHROOM TIP GASTROSTOMY TUBE (K872531)Medical Innovations Corp.1987-09-04
LAKE CATHETER CARE KIT (K872750)Lake Medical Products, Inc.1987-09-03
MODEL 1858 CAVRO/PRESSURE MODULE (K872077)Life-Tech Intl., Inc.1987-08-27
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM (K871846)Abbott Laboratories1987-08-26
INFANT FEEDING TUBE (K872097)Tri-State Hospital Supply Corp.1987-08-25
CODMAN FLEXIBLE ENDOSCOPE (K871978)Codman & Shurtleff, Inc.1987-08-25
INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT (K872096)Tri-State Hospital Supply Corp.1987-08-25
MMG URO-SELF CATHETER (K871999)Medical Marketing Group1987-08-25
MANAN TURNER STYLE NEEDLE (K873208)Manan Manufacturing Co., Inc.1987-08-25
BIOPSY NEEDLE GUIDE KIT, STERILE (K871467)Amedic USA1987-08-21
OSTO-PURE (K871738)Clearchem Corp.1987-08-12
ENURESIS ALARM (K871787)Dilorenzo Engineering Co.1987-08-10
BIOPSY FORCEPS (K871710)Frantz Medical Development, Ltd.1987-08-10
MODIFIED MULTI-LUMEN NASOGASTRIC TUBE (K871691)Bissell Medical Products, Inc.1987-08-10
ANTIMICROBIAL FOLEY CATHETER (K871429)American Pharmaseal Div. Ahsc1987-08-10
ENTRIMIT GRAVITY FEEDING SET (K871528)Biosearch Medical Products, Inc.1987-08-10
PH MONITORING SYSTEM (K872929)Sensatronix Medical Systems, Inc.1987-08-10
INTECARE PEDIATRIC URINE COLLECTOR (K871789)Mercury Enterprises, Inc.1987-08-10
MOSS(R) GASTROSTOMY TUBE CAT #5-17719 (K871554)Mfg. and Research, Inc.1987-07-21
WASHING/INJECTION NEEDLE (K872060)Endovations1987-07-21
VAS-CATH PERITONEAL DIALYSIS CATHETER (K871817)Vas-Cath of Canada , Ltd.1987-07-16
UROVIEW (K872022)Oec-Diasonics, Inc.1987-07-16
DELFLEX RIGID DRAIN CONTAINER (K871155)Delmed, Inc.1987-07-16
MODIFIED LABELING FOR AMUKIN-50% (K871583)Amuchina Intl., Inc.1987-07-09
PALEX (R) OSTOMY (K871628)Industrias Palex C/O Dma Med-Chem Corp.1987-07-08
ACID FUCHSIN SOLUTIONS (K870889)D.R.G. Scientific Industries1987-07-08
ENTERAL ADMINISTRATION SET (K870623)Plasco, Inc.1987-06-26
JUDD URETHAL CATHETER CONTAINER (K864592)Phil Judd, Inc.1987-06-24
DOTOLO COLON HYDROTHERAPY INSTRUMENT (K870534)Dotolo Research Corp. C/O Keller and Heckman1987-06-18
FLEXIBLE BIOPSY FORCEP (K871809)Surgi-Aid Endoscopics, Inc.1987-06-18
ADULT PERM-CATH 40CM. (K871749)Quinton, Inc.1987-06-17
VAN-TEC REUSABLE HELICAL STONE BASKET (K871777)Van-Tec, Inc.1987-06-17
NEO-I TEMPERATURE & CONDUCTIVITY METER (K871708)Automata, Inc.1987-06-17
HELICAL STONE BASKET (DISPOSABLE) (K871779)Van-Tec, Inc.1987-06-17
PERM-CATH CATHETER KIT (K871942)Quinton, Inc.1987-06-17
VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH (K871488)Vas-Cath of Canada , Ltd.1987-06-12
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (K871471)Travenol Laboratories, S.A.1987-06-12
VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (K871487)Vas-Cath of Canada , Ltd.1987-06-12
SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE (K871282)Synectics-Dantec1987-06-10
CONVEEN(R) LEG-BAG (600 ML) (K871643)Coloplast A/S1987-06-10
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) (K871610)Coloplast A/S1987-06-10
URETERAL STENT (K871667)Penn Medical Devices, Inc.1987-06-10
UROSCAN (K870855)Endotherapeutics1987-06-09
ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET (K871019)Entech, Inc.1987-06-09
ACTRIL FOR KIDNEY MACHINE DISINFECTANT (K861730)Renal Systems, Inc.1987-06-09
BARD BIOPTY BIOPSY SYSTEM (K871390)C.R. Bard, Inc.1987-06-05
ENTROSET-SW (K871003)White River (Tm)1987-06-04
KODNER ANAL PERIONEAL RETRACTOR (K870897)Sur-Med Instruments, Inc.1987-06-04
FREEDOM SET II WITH TRIFLEX VALVE (K870626)Delmed, Inc.1987-06-03
HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS (K870979)Inventory Supply Corp.1987-06-03
SECOND NATURE(TM) (K871387)Advanced Clinical Products, Inc.1987-05-29
HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H (K871236)National Medical Care, Medical Products Div., Inc.1987-05-29
KITS AND TRAYS FOR DIALYSIS USE (K871630)Dove Medical Supplies1987-05-26
BLOXOM IRRIGATOR (K871791)I.B. Bloxom C/O Hogan & Hartson1987-05-20
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