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Gastroenterology, Urology

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

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RecordFirmDate
UROPUMP TUBE & DAMPING CHAMGER (K953451)Life-Tech Intl., Inc.1995-10-05
ALTR NOVA 110 HEMODIALYZER (K952983)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
ALTREX 110 HEMODIALYZER (K952982)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
3DSEE (K951646)Intl. Telepresence Corp.1995-10-04
BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 (K954278)Beta Medical Products, Inc.1995-10-02
INFINITECH LIGHTED INFUSION CANNULA (K946136)Surgical Technologies, Inc.1995-10-02
THE TULIP LARGE SOFT TISSUE RETRACTOR (K952980)The Tulip Mfg. Co.1995-09-29
MICROSURGE THORACOSCOPIC ACCESS SYSTEM (K953121)Microsurge, Inc.1995-09-29
BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR (K953410)Springfield Surgical Instruments1995-09-29
TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE (K954265)Promex, Inc.1995-09-29
THE TULIP SMALL SOFT TISSUE RETRACTOR (K952935)The Tulip Mfg. Co.1995-09-29
NORTHGATE FLOW ASSIST TUBING FOR UROLOGY (K943361)Northgate Technologies, Inc.1995-09-29
ENDOLUMINAL ACCESS TUBE (K941228)Med Institute, Inc.1995-09-27
URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT (K951260)Biosearch Medical Products, Inc.1995-09-27
TWIN SILICONE CATHETER (K923691)Medical Components, Inc.1995-09-25
WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA (K953086)Woodbine Optical Corp.1995-09-22
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT (K954231)Promex, Inc.1995-09-22
THE TULIP J DISSECTOR (K952965)The Tulip Mfg. Co.1995-09-22
XLS-300 XENON LIGHT SOURCE (K953924)Specialties of Surgery1995-09-21
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR (K953951)Wilson-Cook Medical, Inc.1995-09-19
DEXIDE ENDO-LUBE KIT (K953611)Dexide, Inc.1995-09-15
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS (K952342)Cobe Renal Care, Inc.1995-09-15
BIOACCESS BONE BIOPSY SYSTEM (K954151)Bioaccess, Inc.1995-09-15
ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) (K951482)Micro-Medical Devices, Inc.1995-09-14
CONVEEN LEG BAG STRAP (K953783)Coloplast Corp.1995-09-13
DILATATION CATHETER, BALLOON (K953004)Boston Scientific Corp1995-09-13
INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS (K945498)Instent, Inc.1995-09-12
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE (K954155)Promex, Inc.1995-09-12
ARTICULATING RETRACTOR TISSUE RETRACTORS (K953348)Gm Engineering, Inc.1995-09-12
ACCESS POINT (K953376)Access Surgical Intl., Inc.1995-09-12
FASCIA CLOSURE DEVICE (K954011)KARL STORZ Endoscopy-America, Inc.1995-09-11
ANALGRAPH (K941801)Sandhill Scientific, Inc.1995-09-08
UROVISION JANUS (K953353)Life-Tech Intl., Inc.1995-09-08
QUIK-STITCH (K953123)Coral Medical, Inc.1995-09-08
GAMBRO LUNDIA 94-500 DIALYZER (K945746)Cobe Renal Care, Inc.1995-09-08
REDDY ILLUMINATOR (K950960)Luxtec Corp.1995-09-08
NG SECURE (K953375)M.C. Johnson Co., Inc.1995-09-08
LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE (K951990)Schoelly Technologies, Inc.1995-09-08
URESIL INTRODUCING NEEDLE (K953923)Uresil Corp.1995-09-08
GAMBRO LUNDIA 94-600 DIALYZER (K945747)Cobe Renal Care, Inc.1995-09-08
INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS (K924387)Instent, Inc.1995-09-08
BIOPSY NEEDLE (K953880)Biopsys Medical, Inc.1995-09-08
GIP/MEDI-GLOBE ERCP CATHETERS (K953827)Medi-Globe Corp.1995-09-01
GAMP & ASSOCIATES DISPOSABLE BARE END FIBER (K952580)Gamp & Assoc.1995-09-01
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (K952586)Gamp & Assoc.1995-09-01
IMAGYN ENDOSCOPE (K951996)Imagyn Medical, Inc.1995-09-01
GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK (K952584)Gamp & Assoc.1995-09-01
ELLMAN LAPTRODE (K953440)North American Technical Services Corp.1995-08-29
LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH (K953243)Devmed Group, Inc.1995-08-28
PRG BUTTON (K946140)Applied Medical Technologies1995-08-28
DIALYZER REPROCESSING SYSTEM (K944492)G.E.M. Water Systems1995-08-28
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (K945480)Harry A. Schlakman1995-08-28
IMAGYN ENDOSCOPE SHEATH (K951974)Imagyn Medical, Inc.1995-08-28
SWISS LITHOCLAST LITHOTRIPTER (K951531)Electro Medical Systems SA1995-08-24
ROLLER ELECTRODE (K951863)Olympus America, Inc.1995-08-24
ASEPTECH PORTABLE RO+ SYSTEM (K924695)Dayton Water Systems1995-08-24
FLOLAB (K951442)Synectics Medical, Inc.1995-08-24
AQUISEN (K952583)Aquintel, Inc.1995-08-24
KSEA EXTRACTION BAG (K953549)KARL STORZ Endoscopy-America, Inc.1995-08-21
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE (K953232)Hollister, Inc.1995-08-18
ADI CATHETER WITH VALVE (K952924)Asia Dynamics, Inc.1995-08-18
LINDNER/GOLOMB SP INTRODUCING SOUND (K953024)Cook Urological, Inc.1995-08-18
THE ASSISTANT (K952841)Apple Medical Corp.1995-08-18
RIZA-RIBE NEEDLE (K953441)R-Med, Inc.1995-08-18
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER (K953481)American Hydro-Surgical Instruments, Inc.1995-08-16
ULTRATHIN URETEROSCOPES (K951855)Olympus America, Inc.1995-08-16
BIPOLAR COAGULATING FORCEPS (K953509)KARL STORZ Endoscopy-America, Inc.1995-08-16
PROSYS LEG BAG (K952208)Convatec, A Division of E.R. Squibb & Sons1995-08-15
URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (K943801)Rocket of London, Ltd.1995-08-15
RMI HEMOCONCENTRATOR (K951344)Research Medical, Inc.1995-08-15
PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION) (K953561)Origin Medsystems, Inc.1995-08-11
SERIM HISENSE TEST KIT (K952215)Serim Research Corp.1995-08-09
KARL STORZ ENDOSCOPY POWDER BLOWER (K952443)KARL STORZ Endoscopy-America, Inc.1995-08-09
THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA (K952278)General Surgical Innovations1995-08-07
SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA (K952444)Adjacent Surgical, Inc.1995-08-07
URINARY DRAINAGE BAG (K951597)Key Medical Services, Inc.1995-08-04
IMAGYN UROSCOPE (K953201)Imagyn Medical, Inc.1995-08-02
ABSORBALBE ANCHOR (K944051)Mitek Surgical Products, Inc.1995-08-02
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR (K946080)Portable Power Systems, Inc.1995-08-02
INJECTION NEEDLE (K953338)Boston Scientific Corp1995-08-02
VIDEO SIGMOIDOSCOPE (K950429)Welch Allyn, Inc.1995-08-01
WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT (K952691)Welch Allyn, Inc.1995-07-31
ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE (K952842)Ethicon Endo-Surgery, Inc.1995-07-31
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE (K952926)Wrightmedicaltechnologyinc1995-07-31
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ (K952638)Baxter Edwards1995-07-28
COLD LIGHT SOURCE LOS XL-A 100 (K952028)Laser-Optik-Systeme GmbH & Co. KG1995-07-27
BRIMFIELD PRECISION DETACHABLE SCISSOR (K952785)Springfield Surgical Instruments1995-07-26
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (K952563)The Tulip Mfg. Co.1995-07-25
XENON LIGHT SOURCE MODEL 5121 (K952696)Richard Wolf Medical Instruments Corp.1995-07-25
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE (K952187)Rusch, Inc.1995-07-25
EPX-310 VIDEO PROCESSOR (ENDOSCOPY) (K950417)Marks & Murase1995-07-21
DEEPVISON (K942910)Automated Medical Products Corp.1995-07-21
CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS (K951972)Cabot Medical Corp.1995-07-21
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS (K952574)KARL STORZ Endoscopy-America, Inc.1995-07-20
GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY (K923488)Applied Medical Technologies1995-07-20
FORCEPS, BIOPSY, NON-ELECTRIC (K952863)Annex Medical, Inc.1995-07-19
METAL URETERAL BASKET STONE DISLODGER (K951532)Annex Medical, Inc.1995-07-19
XXL BALLOON DILATATION CATHETER (K952656)Boston Scientific Corp1995-07-19
POWER RESECTOSCOPE CUTTING LOOP (K951897)Power Analytics Corp.1995-07-18
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (K952082)Rochester Medical Corp.1995-07-18
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