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Gastroenterology, Urology

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

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RecordFirmDate
CLOSED URINARY DRAINAGE UNIT (K843698)Pathfinder Intl. Corp.1984-12-17
ACUTE HEMODIALYSIS TRAYS (K844612)Packaging Technologies, Inc.1984-12-17
CLAMP, TUBING, LINE (K844121)Dyn-A-Med Products1984-12-17
ULTRASONIC LITHOTRIPTOR 300A (K842024)Fibra Sonics, Inc.1984-12-11
KARL STORZ 27086KC ULTRASONIC LITHOTRI (K843101)KARL STORZ Endoscopy-America, Inc.1984-12-11
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI (K844174)Exco, Inc.1984-12-07
PERCUTANEOUS GASTROSTOMY TUBE (K842174)Mount Carmel Mercy Hospital1984-12-07
FOCUSCOPE UNIVERSAL SYSTEM (K843900)Medical Diagnostics, Ca.1984-12-06
PHARMA-PLAST URIDROP-URIDOME (K843478)Zimmar Consulting , Ltd.1984-12-05
PHARMA-PLAST RECTAL TIP (K843477)Zimmar Consulting , Ltd.1984-12-05
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR (K844222)Biosearch Medical Products, Inc.1984-12-05
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN (K844406)Johnson & Johnson Professionals, Inc.1984-11-29
UNITED SKIN BARRIERS (K844046)Howmedica Corp.1984-11-29
EPHAR (K843214)Akron City Hospital1984-11-29
NORTA SILICONIZED LATEX BALLOON CATH. (K842420)Beiersdorf, Inc.1984-11-21
9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE (K843975)Superior Plastic Products Corp.1984-11-20
ACCUMETER ELECTRONIC URINEMETER SYSTEM (K844030)Travenol Laboratories, S.A.1984-11-20
UNILYTE A (K843623)Medical Enterprises, Ltd.1984-11-16
URITROL-M (K842808)The Washington Group, Inc.1984-11-16
TRANQUILITY (K843869)Principle Business Ent.1984-11-16
ASN MONITOR SINGLE NEEDLE MONITOR (K843531)Organon Teknika Corp.1984-11-16
SCD STERILE CONNECTION DEVICE (K844144)E.I. Dupont DE Nemours & Co., Inc.1984-11-16
SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT (K842690)Synectics AB1984-11-08
MALLEABLE PENILE PROSTHESIS (K843280)Mentor Corp.1984-10-24
JIMMY JOHN III (K842083)Colon Therapeutics1984-10-24
MOLINEA INCONTINENT PAD (K843404)Paul Hartmann Corp.1984-10-19
MOLICARE (K843405)Paul Hartmann Corp.1984-10-19
WET-STOP (K842547)Palco Laboratories, Inc.1984-10-19
UROPUMP MODEL 1711 (K843224)Life-Tech Intl., Inc.1984-10-19
MOLINEA PANTY (K843403)Paul Hartmann Corp.1984-10-19
AMER. BENTLEY HEMOFILTER HOLDER HFH-1 (K843504)American Bentley1984-10-18
AMER. BENTLEY CONTINU-BLOOD PROCESSOR- (K841585)American Bentley1984-10-18
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE (K842481)American Edwards Laboratories1984-10-18
HOLLOW FIBER DIALYZER (K843632)Travenol Laboratories, S.A.1984-10-18
INFRARED COAGULATOR (K842810)Endo Lase, Inc.1984-10-18
EXTENDED LIFE CAPD SOLUTION TRANSFER (K842885)Travenol Laboratories, S.A.1984-10-18
PHARMA-PLAST CONNECTING TUBE TYPE URIN- (K843481)Zimmar Consulting , Ltd.1984-10-18
FRESENIUS HAEMODIALYSIS A2008 (K843014)Seratronics, Inc.1984-10-18
PHARMA-PLAST LEG BAG (K843479)Zimmar Consulting , Ltd.1984-10-11
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP (K843305)C.R. Bard, Inc.1984-10-11
PHARMA-PLAST URINARY DRAINAGE BAG 2000 (K843480)Zimmar Consulting , Ltd.1984-10-11
GREEN CROSS URINARY DRAINAGE BAG (K843117)Tech-Cons Ltd., Intl.1984-10-11
GAUDERER GASTROSTOMY BUTTON (K843392)American V. Mueller1984-10-11
MEDIFLEX DRAINAGE BAG (K843126)Mediflex Intl.1984-10-04
SEXTON CYSTOTOMY URINE PUMP (K843158)Holter-Hausner Intl.1984-10-04
WAREXIN RECOMMENDED ALTERNATIVE DIALYZ (K843520)Mesa Medical, Inc.1984-10-04
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y (K843198)Life-Tech Intl., Inc.1984-10-04
DILATOR/SHEATH SET (K842632)American Edwards Laboratories1984-10-02
AMER. EDWARDS LAB DIAFLEX URETERAL DILA (K842639)American Edwards Laboratories1984-10-02
CATH-TECH CHOLANGIOGRAPHY CATHETER (K842147)Catheter Technology Corp.1984-10-02
HEMODIAL CONCENTRATE MIXING APPARATUS (K842225)Lmf Medical Research & Manufacturing, Inc.1984-10-02
ESOPHAGEAL DILATOR SET (K842679)Mill-Rose Laboratory1984-10-02
DIAFLEX NEPHROSTOMY BALLOON DILATOR (K842206)American Edwards Laboratories1984-10-02
SUR-FIT IRRIGATION ADAPTER FACEPLATE (K842398)Convatec, A Division of E.R. Squibb & Sons1984-10-01
BRIMFIELD CANNULATED MAGNETIC RETRIEVER (K843135)Brimfield Scientific Instruments1984-09-26
CAPILLARY FLOW DIALYZERS (K840937)Travenol Laboratories, S.A.1984-09-12
HEMOPERFUSION PROCEDURE W/REDY 2000 (K842513)Organon Teknika Corp.1984-09-12
OSTOMY OR UROSTOMY ABDOMINAL BELT OS (K842119)Atlas Surgical Belt Co., Inc.1984-09-10
URETHRAL CATHETERIZATION TRAY (K842866)Inmed Corp.1984-09-10
PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG (K841986)Protomed Corp.1984-09-10
FORMACLEAR- & MULTIPLE (K842131)Rna Medical Corp.1984-09-10
AIMED FOLEY CATHETER VARIOUS SIZES (K842228)Tech-Cons Ltd., Intl.1984-09-10
PERCUFIX CATHETER CUFF (K842890)Medi-Tech, Inc.1984-09-04
LASER RECTOSCOPE SET 784 (K842997)Laser Industries , Ltd.1984-08-27
FLUID WARMER (K842302)Organon Teknika Corp.1984-08-27
THE DENVER PLEURAL-PERITONEAL SHUNT (K842139)Denver Biomedicals, Inc.1984-08-27
INTERMITTENT URETHRAL CATHETER TRAY (K841769)Seamless Hospital Products Co.1984-08-24
HOLLOW FIBER DIALYZERS (K840845)Travenol Laboratories, S.A.1984-08-16
VIVONEX TUNG STEN TIP TUBE (K842841)Norwich Eaton Pharmaceuticals, Inc.1984-08-14
IVAC KEOFEED HYDROPHILIC FEEDING TUBE (K842589)Y1984-08-14
MIC GASTROSTOMY TUBE (K842076)Medical Innovations Corp.1984-08-14
R.L. MEDICAL TWIN LIGHT SOURCE (K842609)Tridak Division of Indicon, Inc.1984-08-09
VAN-TEC OCCLUSION BALLOON CATHETER (K841941)Van-Tec, Inc.1984-08-08
ACCUSEAL LEG BAGS & EXTENSION TUBES (K842396)Convatec, A Division of E.R. Squibb & Sons1984-08-08
CORPAK URINARY DRAINAGE BAG (K842257)Corpak Co.1984-08-08
URIHESIVE SYS MALE EXTERNAL CATHETER (K842397)Convatec, A Division of E.R. Squibb & Sons1984-08-08
G.I. CLEANSING KIT (K842130)Mmi, Inc.1984-08-08
SUR-FIT NIGHT DRAINAGE CONTAINER SET (K842395)Convatec, A Division of E.R. Squibb & Sons1984-08-08
LIFEMED LIFECOIL CATHETERS (K841929)Lifemed of California1984-08-08
EMG MODULE, EMG1, W/OPTIONAL SPEAKER (K842124)Endotek Corp.1984-08-08
VACCESS FEMORAL CANNULA (K842864)Vas-Cath of Canada , Ltd.1984-08-08
VAN-TEC URETERAL DILATION BALLOON CATH (K841940)Van-Tec, Inc.1984-08-03
ASCORBIC ACID (K842215)Organon Teknika Corp.1984-08-02
GASTROINTESTINAL DILATOR (K841310)Thomas J. Fogarty, M.D.1984-07-31
CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE (K832290)Travenol Laboratories, S.A.1984-07-31
MONOXYCHLOROSENE WAREXIN (K834455)Guardian Chemical1984-07-31
PACKETS FOR THE PREP OF DIALYSATES & (K842154)Organon Teknika Corp.1984-07-31
HEMODIALYSIS BATH CONCENTRATE SOLUTION (K842058)Pharmaceutical Development Systems1984-07-26
ENTERAL FEEDING BOTTLE (K841945)Superior Plastic Products Corp.1984-07-26
DUO FLOW CATHETER-MC 54 (K842416)Medical Components, Inc.1984-07-26
ESOPHAGEAL TUBE (K841349)E. Benson Hood Laboratories, Inc.1984-07-23
CHESEBROUGH-POND'S REUSABLE URINARY LEG (K842553)Chesebrough-Pond'S U.S.A. Co.1984-07-20
SEGURA BASKET (K841942)Van-Tec, Inc.1984-07-19
PROXIMA 1 PH MONITOR (K841384)American Endoscopy, Inc.1984-07-19
ULTRA SHIELD BRIEFS (K841953)Ipco Corp.1984-07-19
CORPAK FOLEY CATH TRAY W/16FR. TEFLON (K841819)Corpak Co.1984-07-19
OLYMPUS KC-10 MOBILE DISINFEC-STAT (K841331)Keymed, Inc.1984-07-19
STERILE, FOLEY CATHETERS W/PTFE COAT (K841678)Abco Dealers, Inc.1984-07-19
CODE 17-ENDOSCOPE DEODORANT (K840208)Knox Laboratories1984-07-19
COLON IRRIGATION UNIT (K840613)Colenz Co.1984-07-17
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