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Gastroenterology, Urology

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

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RecordFirmDate
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (K023666)Rusch Intl.2003-06-17
URINARY CATHETERS (K031409)Promedic, Inc.2003-06-17
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 (K030099)Baxter Healthcare Corp2003-06-17
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K031197)Cordis Corp.2003-06-16
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER (K030020)C.R. Bard, Inc.2003-06-16
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER (K024010)The Kendall Company Div. of Tyco Healthcare Group2003-06-11
HOBBS MISTIFIER SPRAY CATHETER (K030765)Hobbs Medical, Inc.2003-06-09
MODIFICATION TO CAVERMAP SURGICAL AID (K031527)Blue Torch Medical Technologies2003-06-05
MERDOC SYSTEM (K022393)Stryker Endoscopy2003-06-05
SCB COMPUTER MOTION INTERFACE CONTROLLER (K030718)Computer Motion, Inc.2003-06-05
3-CCD DIGITAL CAMERA SYSTEM (K031098)Linvatec Corp.2003-06-04
LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112 (K030824)Hakko Medical Co., Ltd.2003-06-04
SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH (K030684)Acmi Corporation2003-06-03
NANMA VACUUM PUMP (K030913)Nanma Mfg Co., Ltd.2003-06-03
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) (K030839)Medtronic Ave, Inc.2003-05-30
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND (K030813)Primary Care Solutions, Inc.2003-05-30
FRESENIUS ULTRAFLUX HEMODIALYZER (K031378)Fresenius Medical Care North America2003-05-30
WATER PURIFICATION SYSTEM (K022448)Purity Water Company of San Antonio, Inc.2003-05-28
AMSURE URETHRAL CATHETERIZATION TRAY (K030712)Amsino International, Inc.2003-05-23
DEFLECTING URETERAL ACCESS SHEATH (K030642)Applied Medical Resources Corp.2003-05-23
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H (K030592)Gambro Renal Care Products2003-05-23
AMSURE FOLEY INSERTION TRAY (K030664)Amsino International, Inc.2003-05-23
PATHWAY STM-10 PELVIC FLOOR STIMULATOR (K030039)The Prometheus Group2003-05-23
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE (K031344)Ranfac, Corp.2003-05-23
NAVIGATOR URETERAL ACCESS SHEATH SET (K030956)Boston Scientific Corp2003-05-23
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 (K031262)Ndo Surgical, Inc.2003-05-23
MODIFICATION TO FOSSA URETERAL STONE SWEEPER (K031292)Fossa Medical, Inc.2003-05-22
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 (K031379)Smith & Nephew, Inc.2003-05-22
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE (K031001)Acmi Corporation2003-05-21
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES (K030497)Fresenius Medical Care2003-05-20
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 (K030502)Medcomp2003-05-20
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM (K030512)Guidant Corp.2003-05-14
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR (K030209)The Kendall Company2003-05-13
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST (K030443)Nastech Pharmaceutical Company, Inc.2003-05-09
DIATEK CANNON-CATHETER, MODEL CC5500 (K022662)Arrow Intl., Inc.2003-05-09
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (K031347)Olympus Optical Co., Ltd.2003-05-09
LUMINEXX ENDOSCOPIC BILIARY STENT (K031186)C.R. Bard, Inc.2003-05-06
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (K023615)Gambro Renal Products2003-05-06
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K030346)Fmd, LLC2003-05-02
HEMO-STREAM HEMODIALYSIS CATHETER SET (K023847)Rex Medical2003-04-30
ATHENA PELVIC MUSCLE TRAINER (K023905)Athena Feminine Technologies, Inc.2003-04-30
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE (K030451)Carbon Medical Technologies, Inc.2003-04-30
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 (K030974)Baxter Healthcare Corp2003-04-25
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY (K030983)Deltec, Inc.2003-04-25
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 (K030975)Baxter Healthcare Corp2003-04-25
VITALCARE URETHRAL CATHETER (K021938)Vitalcare, Inc.2003-04-22
VITALCARE FOLEY CATHETER (K021939)Vitalcare, Inc.2003-04-22
ENDOSCOPIC PLICATION SYSTEM (K023234)Ndo Surgical, Inc.2003-04-17
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT (K030855)Boston Scientific Corp2003-04-17
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 (K030854)E-Z-Em, Inc.2003-04-16
PANCREATIC DRAINAGE TUBE (K021672)Aomori Olympus Co., Ltd.2003-04-16
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS (K023308)Orbus Medical Technologies2003-04-14
LINA-BAG, MODELS LB-60, LB-100 (K030422)Lina Medical Cml Aps2003-04-14
VITALCARE URETHRAL CATHETER RED RUBBER (K023872)Vitalcare, Inc.2003-04-10
NOMAD ND1000M AUGMENTED VISION SYSTEM (K030940)Microvision Incorporated2003-04-09
PORTABLE RO+ MODEL MROS09 (K030059)Ameriwater2003-04-07
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 (K022112)Fortune Medical Instrument Corp.2003-04-03
JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 (K030053)Jomed AG2003-03-31
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT (K030645)Boston Scientific Corp2003-03-25
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (K030194)The Olympus Optical Co.2003-03-24
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT (K024301)Lsi Solutions2003-03-24
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM (K030107)Boston Scientific Corp2003-03-21
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS (K023162)Fresenius Medical Care2003-03-20
OPTION-VF URINARY CATHETER, FV14218 (K023090)Opticon Medical, Inc.2003-03-19
SIGHTFIX (K024251)World of Medicine Lemke GmbH2003-03-18
BARD AQUAGUIDE URETERAL CONDUIT (K030438)C.R. Bard, Inc.2003-03-17
MODIFICATION TO CONTOUR POLARIS URETERAL STENT (K030503)Boston Scientific Corp2003-03-17
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT (K024124)Chf Solutions, Inc.2003-03-14
VACUFLASH BIOPSY SYSTEM (K024089)Bip USA, Inc.2003-03-11
IRRIGATION SETS (K023808)International Medsurg Connection2003-03-10
AMERICAN CATHETER, MODEL W3 (K030538)Catheter, LLC2003-03-10
LIFESTENT BILIARY ENDOPROSTHESIS (K023121)Orbus Medical Technologies2003-03-10
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM (K030409)Cordis Corp.2003-03-10
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR (K022412)Fresenius Medical Care North America2003-03-05
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS (K024015)Alliance Medical Corp.2003-03-04
CATHETER CONNECTOR (K023690)World Metals, Inc.2003-02-28
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE (K023985)Rockwell Medical Technologies, Inc.2003-02-28
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K022980)Given Imaging , Ltd.2003-02-27
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM (K030315)Ultroid, LLC2003-02-27
MEDCOMP SC4 (K022678)Medcomp2003-02-24
SYNTRA + DIALYZER, MODEL 200 (K023664)Baxter Healthcare Corp2003-02-21
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K030240)Computer Motion, Inc.2003-02-21
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE (K023903)Wilson-Cook Medical, Inc.2003-02-20
ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 (K023630)Guidant Corporation, Cardiac Surgery2003-02-20
ENDO-GLIDE GUIDEWIRE (K023603)Endo-Therapeutics, Inc.2003-02-19
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM (K023906)The Prometheus Group2003-02-19
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE (K023843)Opus Medical, Inc.2003-02-14
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (K023401)Pentax Precision Instrument Corp.2003-02-11
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS (K023248)Orbus Medical Technologies2003-02-11
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM (K022747)Hydropure Systems, Inc.2003-02-11
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS (K022221)Deltec, Inc.2003-01-30
1-CCD ENDOCAM 5520 SYSTEM (K023659)Richard Wolf Medical Instruments Corp.2003-01-29
SPEEDICATH (K023254)Coloplast Corp.2003-01-27
BARD ER URETERAL STENT WITH SUTURE (K022447)C.R. Bard, Inc.2003-01-23
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (K010714)Medi-Globe Corp.2003-01-21
TRIPTER X-1 COMPACT DUET (K023535)Direx Systems Corp.2003-01-17
MODIFICATION TO TEMNO BIOPSY NEEDLES (K024120)Allegiance Healthcare Corp.2003-01-15
ULTROID HEMORRHOID MANAGEMENT SYSTEM (K023706)Ultroid, LLC2003-01-14
ENDOSCOPIC LIGHT SOURCE XL180/L3 (K023468)World of Medicine Lemke GmbH2003-01-14
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K024294)Computer Motion, Inc.2003-01-08
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