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Gastroenterology, Urology

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

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RecordFirmDate
MEDAX UNIPERSONALE SRL (K092338)Medax Unipersonale Srl2011-05-27
DIRECTVISION CATHETER, UNCOATED (K110214)Percuvision2011-05-27
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR (K102466)Fujinon, Inc.2011-05-25
GELPOINT PATH (K110792)Applied Medical Resources Corp.2011-05-23
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM (K110578)Mar Cor Purification, Inc.2011-05-20
PHOENIX HEMODIALYSIS DELIVERY SYSTEM (K103832)Gambro Renal Products, Inc.2011-05-20
UNIMAX SUCTION IRRIGATION SET (K103509)Unimax Medical Systems, Inc.2011-05-19
FUJINON ULTRASONIC PROCESSOR (K111243)Fujinon, Inc.2011-05-16
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (K102887)Percutaneous Systems, Inc.2011-05-16
VR MEDICAL ENTERAL ORAL SYRINGE (K110853)Vr Medical2011-05-13
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES (K103025)Given Imaging , Ltd.2011-05-13
MUSTANG BALLOON DILATAION CATHETERS (K110122)Boston Scientific2011-05-12
UPD-Y0003 (K103312)Olympus Medical Systems Corporation2011-05-12
WEXLER ENDOSCOPE ACCESSORIES (K110121)Microsurgical Laboratories,Inc.Dba Wexler Surgical2011-05-10
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION (K103611)United States Endoscopy Group, Inc.2011-05-09
UNIMAX SPECIMEN RETRIEVAL SYSTEM (K103510)Unimax Medical Systems, Inc.2011-05-06
DIAMOND-FLEX(R) GRASPERS (K110257)Carefusion 2200, Inc.2011-05-06
LIC INSTRUMENT PROCESSING SYSTEM (K101158)Langford IC Systems, Inc.2011-05-06
ASPIRA PERITONEAL DRAINAGE SYSTEM (K110396)C.R. Bard, Inc.2011-05-06
VAPRO PLUS INTERMITTENT CATHETER (K110862)Hollister Incorporated2011-04-26
SOLCART B (K102194)B. Braun Avitum AG2011-04-25
CRE BALLOON DILATATION CATHETER (K110833)Boston Scientific Corporation2011-04-20
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER (K110887)Boston Scientific Corporation2011-04-14
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 (K101581)Intuitive Surgical, Inc.2011-04-08
MULTIPLE BIOPSY SYSTEM (K103326)United States Endoscopy Group, Inc.2011-04-06
EM-9000 (K101482)Elite Medical, Inc.2011-03-31
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R (K102936)Baxter Healthcare Corp2011-03-30
SOPRO 281 (K103813)Sopro2011-03-22
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES (K103696)Erbe USA, Inc.2011-03-22
BACKSTOP CATHETER (K110491)Pluromed, Inc.2011-03-16
RELIANCE ENDOSCOPE PROCESSING SYSTEM (K110453)STERIS Corporation2011-03-16
SPIDER STANDARD AND ADVANCED (K102839)Transenterix, Inc.2011-03-15
COUDE/ OR TIEMANN (K103371)Degania Silicone , Ltd.2011-03-11
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES (K101250)Given Imaging , Ltd.2011-03-07
SURGISURE TISSUE REMOVAL SYSTEM (K103741)Interlace Medical, Inc.2011-03-02
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (K103647)Thd Spa2011-03-01
SINGLE USE BILIARY DRAINAGE STENT V (K103478)Olympus Medical Systems Corporation2011-02-24
SILS PORT (K103253)Coviden (Formerly Registered AS US Surgical, A Div2011-02-24
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO (K103264)Olympus Medical Systems Corporation2011-02-23
STEMPRO MSC SFM (K103302)Life Technologies Corporation2011-02-18
SYSTEMS INTEGRATION (K102763)Olympus Medical Systems Corporation2011-02-15
SYSLOC MINI V3 (K110157)JMS North America Corporation2011-02-11
VENOFER PUMP (K103564)Renal Solutions, Inc.2011-02-10
REDSENSE-ALARM UNIT AND SENSOR (K103242)Redsense Medical AB2011-02-10
VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, (K100533)Vibrynt, Inc.2011-02-08
HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH (K101900)Hakki Medical Technologies, Inc.2011-02-07
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 (K101077)Intuitive Surgical, Inc.2011-02-04
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 (K101743)Intuitive Surgical, Inc.2011-02-04
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (K070049)Fresenius Medical Care North America2011-02-03
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS (K102892)Aqua Sciences, Inc.2011-02-03
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER (K102238)Teleflexmedical, Inc.2011-02-01
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE (K103254)Coloplast A/S2011-01-31
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (K110004)Advanced Surgical Concepts2011-01-26
G-PROX EZ ENDOSCOPIC GRASPER (K103688)Usgi Medical2011-01-14
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT (K103088)Given Imaging , Ltd.2011-01-14
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER (K103353)Navilyst Medical, Inc.2011-01-14
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR (K102996)Medivators Reprocessing Systems2011-01-13
EXPECT ENDOSCOPIC ASPIRATION NEEDLE (K110030)Boston Scientific Corp2011-01-12
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS (K102781)Olympus Winter & Ibe GmbH2011-01-11
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 (K101750)Reprocessing Products Corp2011-01-07
BACKSTOP CATHETER (K103349)Pluromed, Inc.2011-01-07
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH (K103043)Adapta Medical, Inc.2011-01-07
LTF-Y0009; MAJ-YOO41; XOEV-3D1 (K102379)Olympus Medical Systems Corporation2011-01-05
BNX FINE NEEDLE ASPIRATION SYSTEM (K103668)Boston Endoscopic Engineering2010-12-30
G-CINCH SUTURE GRASPER (K102931)Usgi Medical2010-12-30
IRRIGATION SYSTEM (K103239)United States Endoscopy Group, Inc.2010-12-30
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE (K102616)Smart Medical Systems , Ltd.2010-12-30
AXIOM FASCIAL CLOSURE SYSTEM (K103412)Axiom Technology Partners, LLC2010-12-30
AED RESECTOSCOPE (K102663)National Advanced Endoscopy Devices, Inc.2010-12-30
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT (K102572)Sainath Intellectual Properties, LLC2010-12-27
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) (K103359)C.R. Bard, Inc.2010-12-27
DEFOGGING AND CLEANING SOLUTION- FLO-X (K102452)Minimally Invasive Devices, LLC2010-12-23
ERBEFLO 2 DISPOSABLE TUBING SYSTEM (K103235)Erbe USA, Inc.2010-12-23
US ENDOSCOPY CYTOLOGY BRUSH (K103437)United States Endoscopy Group, Inc.2010-12-23
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER (K102605)Covidien, LLC, Formerly Registered AS Tyco Healthca2010-12-22
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE (K103109)C.R. Bard, Inc.2010-12-22
RESOLUTION II CLIP (K102764)Boston Scientific Corporation2010-12-22
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM (K102391)C.R. Bard, Inc.2010-12-22
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 (K100451)Gambro Renal Products, Inc.2010-12-21
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (K101715)Fresenius Medical Care North America, Design Cente2010-12-21
ENDO FLIP (K102214)Crospon, Ltd.2010-12-16
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700)Benlan, Inc.2010-12-13
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K093641)Tango3, LLC2010-12-08
RELIANCE ENDOSCOPE PROCESSING SYSTEM (K102244)STERIS Corporation2010-12-03
ENVIEW (TM) (K102179)Carefusion 22002010-12-02
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET (K101428)Ovesco Endoscopy AG2010-12-01
BRAVO PH MONITORING SYSTEM AND ACCESSORIES (K102543)Given Imaging , Ltd.2010-12-01
VITALA CONTINENCE CONTROL DEVICE (K102536)Convatec, Inc.2010-12-01
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA (K101794)Advanced Surgical Concepts2010-11-29
FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE (K102548)Footprint Medical, Inc.2010-11-26
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX (K102519)Flexible Stenting Solutions, Inc.2010-11-22
UNIVERSAL IRRIGATION SOLUTION HYBRID (K102855)Byrne Medical, Inc.2010-11-19
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER (K102043)Rex Medical2010-11-18
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 (K102581)Byrne Medical, Inc.2010-11-08
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER (K102527)Boston Scientific Corporation2010-11-05
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 (K102409)Byrne Medical, Inc.2010-11-04
SPIDER FLEX MONOPOLAR HOOK (K102646)Transenterix, Inc.2010-11-03
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (K100364)Gambro Renal Products, Inc.2010-11-03
CLEARFLUX DIALYZER REPROCESSING SYSTEM (K091360)Novaflux Technologies2010-11-03
PHTIP DISPOSABLE ISFET CATHETER (K102801)E-Cath Co., Ltd.2010-10-26
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