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Gastroenterology, Urology

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

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RecordFirmDate
REPROCESSED TROCARS AND CANNULAS (K012644)Surgical Instruments Service and Savings, Inc.2002-07-29
FOSSA URETERAL STONE SWEEPER (K021602)Fossa Industries, Inc.2002-07-26
CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES (K022169)Parallax Medical, Inc.2002-07-25
PRISMAFLO (K020103)Stihler Electronic GmbH2002-07-24
CRIT-LINE MONITOR III TQA (CLM TQA) (K011741)Hemametrics2002-07-23
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) (K022000)Spire Biomedical, Inc.2002-07-19
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) (K022026)Medtronic Ave, Inc.2002-07-19
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE (K021991)Syncro Medical Innovations, Inc.2002-07-18
INFANT FEEDING TUBES (K020005)Promedic, Inc.2002-07-16
ARM AUTOMATIC REPROCESSING MACHINE (K013713)Alcavis International Incorporated2002-07-15
HORIZONS CYTOLOGY BRUSH (K021998)Horizons Intl. Corp.2002-07-12
TOPCUT (K021525)H.S. Hospital Service S.R.L.2002-07-12
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK (K013634)Bioteque Corp.2002-07-09
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY (K013418)Asahi Medical Co., Ltd.2002-07-09
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P (K014297)Boston Scientific Corp2002-07-09
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A (K021179)Olympus Optical Co., Ltd.2002-07-05
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 (K021824)Guidant Corp.2002-07-02
RUSCH FLONEIL; FLOCATH INTROGEL (K020714)Rusch Intl.2002-07-01
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT (K021140)Fossa Industries, Inc.2002-06-28
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 (K021290)Vista Medical Technologies, Inc.2002-06-28
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K021345)Cordis Corp.2002-06-28
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM (K003720)Lifestream Purfication Systems, LLC2002-06-27
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 (K021036)Intuitive Surgical, Inc.2002-06-26
SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM (K021137)Sanarus Medical, Inc.2002-06-26
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER (K021034)Tfx Medical, Inc.2002-06-26
BMN I TYPE MARROW ASPIRATION NEEDLE (K020987)H.S. Hospital Service S.R.L.2002-06-25
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER (K020985)Tfx Medical, Inc.2002-06-25
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K021729)Sulzer Intratherapeutics, Inc.2002-06-21
HORIZONS HOT BIOPSY FORCEPS (K021706)Horizons Intl. Corp.2002-06-21
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P (K021886)Olympus Optical Co., Ltd.2002-06-19
NAKAO SNARE II AND NAKAO SNARE III (K020891)Granit Medical Innovations2002-06-17
SOPRO LIGHT SOURCES AND ACCESSORIES (K020915)Sopro2002-06-14
INSIGHT, MODEL S980000 (K012232)Sandhill Scientific, Inc.2002-06-07
ENDOSCOPIC LIGHT SOURCE XL202/L3 (K020889)World of Medicine Lemke GmbH2002-06-05
VACURECT VACUUM CONSTRICTION DEVICE (K020969)Vacurect Manufacturing (Pty) , Ltd.2002-06-05
SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET (K013733)Chf Solutions, Inc.2002-06-03
ENTERYX INJECTOR (K013712)Enteric Medical Technologies2002-05-31
IRRIGATING CANNULA (K020614)Ca Guard, Ltd.2002-05-24
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL (K020315)Medcomp2002-05-24
HDM97 (K020908)Ibp Instruments GmbH2002-05-22
APPLIED URETERAL CATHETER (K020577)Applied Medical Resources Corp.2002-05-22
MEDCOMP ASH SPLIT-CATH II (K020465)Medcomp2002-05-22
HDM99 (K020909)Ibp Instruments GmbH2002-05-22
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL (K020867)Worldwide Medical Technologies, LLC2002-05-20
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K021212)Spire Biomedical, Inc.2002-05-17
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (K020430)Diatek, Inc.2002-05-09
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (K021166)Acmi-Circon Corporation2002-05-09
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (K013053)Nanma Mfg Co., Ltd.2002-05-09
WILSON-COOK ZILVER BILIARY STENT (K020788)Wilson-Cook Medical, Inc.2002-05-08
MAINSTREAM WATER PURIFICATION DEVICE (K012716)Prismedical Corp.2002-05-07
PPD BALLOON DILATATION CATHETER (K020379)Telemed Systems, Inc.2002-05-06
INDWELLING FECAL MANAGEMENT SYSTEM (K012113)Bowel Management Systems, LLC2002-05-03
GIVEN DIAGNOSTIC SYSTEM (K020341)Given Imaging , Ltd.2002-05-02
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA (K021074)Olympus America, Inc.2002-05-02
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER (K013471)E.S.W.L. Products, Inc.2002-04-29
REPROCESSED GUIDEWIRES (K012556)Sterilmed, Inc.2002-04-29
LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112 (K020307)Hakko Shoji Co., Ltd.2002-04-26
DIASOL-BICARB (K020230)Diasol, Inc.2002-04-23
NXSTAGE THERAPY SYSTEM (K020858)Nxstage Medical, Inc.2002-04-17
KSEA FIBERSCOPE (K011793)KARL STORZ Endoscopy-America, Inc.2002-04-17
INTRASTENT LD (LARGE DIAMETER) STENT (K020528)Sulzer Intratherapeutics, Inc.2002-04-16
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K020809)Cordis Corp.2002-04-12
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 (K020824)Boston Scientific Corp2002-04-12
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER (K013160)Spire Biomedical, Inc.2002-04-11
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR (K020089)The Kendall Company2002-04-10
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, (K012758)Circon Video2002-04-09
VT-1 (K020154)Pos-T-Vac, Inc.2002-04-04
BIOSUC (K013108)Hakko Medical Co., Ltd.2002-04-04
SUPPORT SLEEVE (K020258)Pos-T-Vac, Inc.2002-04-04
CARIS MINITOME BIOPSY INSTRUMENT (K020024)Artemis Medical, Inc.2002-04-03
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM (K020682)C.R. Bard, Inc.2002-04-02
O'REGAN DISPOSABLE ANOSCOPE (K020702)Canadian Theatre Products , Ltd.2002-03-29
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM (K013551)Computer Motion, Inc.2002-03-28
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB (K010131)Aksys, Ltd.2002-03-26
DAVLITE MICROENDOSCOPE & ACCESSORIES (K020310)Davlite Technologies2002-03-20
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR (K020526)Don Wilson/Wilson-Cook Medical, Inc.2002-03-19
ENDOSCOPIC CAMERA MC404/C3 (K020336)World of Medicine Lemke GmbH2002-03-14
ENDOSCOPIC CAMERA TC804/C4 (K014158)World of Medicine Lemke GmbH2002-03-14
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA (K020270)Sopro2002-03-14
SONOPSY (K013109)Hakko Medical Co., Ltd.2002-03-12
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM (K013677)Usfilter/Ionpure, Inc.2002-03-08
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (K014002)Fortune Medical Instrument Corp.2002-03-04
ENDOPATH DILATING TIP TROCAR, MODEL #512XD (K020428)Ethicon Endo-Surgery, Inc.2002-03-04
LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR (K011269)Nxstage Medical, Inc.2002-03-04
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (K013737)Telemed Systems, Inc.2002-03-01
SANDHILL SCIENTIFIC PEDIATEC PH PROBE (K013951)Sandhill Scientific, Inc.2002-02-28
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM (K013952)Intuitive Surgical, Inc.2002-02-28
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE (K014047)Applied Medical Resources Corp.2002-02-28
RUSCH MILLER-ABBOTT TUBE (K010797)Rusch Intl.2002-02-26
RUSCH CANTOR TUBE (K010798)Rusch Intl.2002-02-26
DFINER UROLOGICAL CATHETER (K013360)Neoseed Technology,Llc2002-02-20
PROTOCO2L INSUFFLATOR MODEL 6400 (K013219)E-Z-Em, Inc.2002-02-19
APPLE MEDICAL MOBIUS ELASTIC RETRACTOR (K014005)Apple Medical Corp.2002-02-15
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) (K013276)Sewoon Medical Co., Ltd.2002-02-15
REPROCESSED STONE RETRIEVAL BASKETS (K012581)Sterilmed, Inc.2002-02-14
REPROCESSED ENDOSCOPIC ELECTRODES (K012685)Sterilmed, Inc.2002-02-14
MODIFICATION TO VISTA STEREOSCOPE SYSTEM (K020301)Vista Medical Technologies, Inc.2002-02-12
RUSCH MEMORY BAG (K013872)Rusch Intl.2002-02-12
STONELITH, MODEL V5 (K011106)Pck Electronic Industry and Trade Co, Ltd.2002-02-11
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K020052)Cordis Corp.2002-02-11
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