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Gastroenterology, Urology

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

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RecordFirmDate
LUMILOC (TM) SAFETY INTRODUCER NEEDLE (K070449)Specialized Health Products International, Inc.2007-06-14
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 (K070198)Ethicon Endo-Surgery, LLC2007-06-13
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE (K071153)Given Imaging , Ltd.2007-06-11
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 (K070320)Edwards Lifesciences Services GmbH2007-06-07
SUNMED FOLEY CATHETERS (K062112)Sunmed, Inc.2007-06-04
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (K070939)Coloplast Manufacturing Us, LLC2007-06-01
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL (K070716)KARL STORZ Endoscopy-America, Inc.2007-05-31
THYROSAMPLER (K062979)Acd Medical Innovation Corp.2007-05-30
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 (K070739)Renal Solutions, Inc.2007-05-25
GASTROSTOMY REPLACEMENT TUBE, MODEL 253 (K070124)Degania Silicone , Ltd.2007-05-23
JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS (K070234)Jms North America Corp.2007-05-22
KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 (K070827)KARL STORZ Endoscopy-America, Inc.2007-05-22
POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM (K070759)Vidacare Corporation2007-05-21
RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 (K071048)Rubicor Medical, Inc.2007-05-15
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM (K062475)The Laryngeal Mask Co., Ltd.2007-05-09
RESONANCE METALLIC URETERAL STENT (K063742)Cook Ireland, Ltd.2007-05-08
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM (K070475)Given Imaging , Ltd.2007-05-07
UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES (K070331)Laborie Medical Technologies2007-05-04
DELTACUT (APPARATUS AND CANNULA) (K063233)PAJUNK GmbH Medizintechnologie2007-04-30
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (K070512)Chf Solutions, Inc.2007-04-27
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K070330)Avantis Medical Systems, Inc.2007-04-24
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N (K070222)Fresenius Medical Care North America2007-04-24
BARD MALECOT AND PEZZER DRAINS (K070879)C.R. Bard, Inc.2007-04-24
COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 (K070091)Cardinal Health, Inc.2007-04-18
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS (K062362)Sarmed Srl2007-04-13
OPUS SMARTSTITCH SUTURE DEVICE (K070671)Arthrocare Corp.2007-04-06
MINI LAP INSTRUMENTS (K070686)Mini Lap Technologies, Inc.2007-04-05
MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM (K070352)Mini Lap Technologies, Inc.2007-04-05
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (K063061)Viasys Medsystems2007-04-02
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES (K070177)Fresenius Medical Care North America2007-03-29
MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM (K070712)Surgical Innovations Group Plc2007-03-28
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR (K063442)Degania Silicone , Ltd.2007-03-26
EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE (K063293)Edwards Lifesciences Services GmbH2007-03-23
FISSO HOLDING SYSTEM (K070509)Baitella AG2007-03-22
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (K062720)Richard Wolf Medical Instruments Corp.2007-03-22
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (K070420)United States Endoscopy Group, Inc.2007-03-19
FUJINON MODEL EG-530N TRANS NASAL INSERTION (K063316)Fujinon, Inc.2007-03-16
UNITIP HIGH RESOLUTION CATHETER (K062222)Unisensor AG2007-03-15
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (K070048)Marian Medical, Inc.2007-03-15
SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA (K063859)Surgiquest, Inc.2007-03-14
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES (K062875)Endogastric Solutions, Inc.2007-03-09
ECONOLITH EM1000 (K063504)Medispec, Ltd.2007-03-09
EXPRESSWAY INTERMITTENT CATHETER (K061766)Percutaneous Systems, Incorporated2007-03-09
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR (K070508)C.R. Bard, Inc.2007-03-09
TROKABONE, TROKABONE STERNAL (K070179)PAJUNK GmbH Medizintechnologie2007-03-07
GUARDIANCATHETER-URINARY DRAINAGE CATHETER (K063795)Marian Medical, Inc.2007-03-05
PS SERIES (K061622)Photonic Optische Gerate Gesmbh & Cokg2007-03-05
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 (K063786)Olympus Medical Systems Corporation2007-03-05
FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE (K060899)Schoelly Imaging, Inc.2007-03-02
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 (K063847)Fujinon, Inc.2007-03-01
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT (K062444)Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.2007-02-22
560 HIGH DEFINITION CAMERA SYSTEM (K070266)Smith & Nephew, Inc.2007-02-22
SOPRO 162 CAMERA (K070102)Sopro2007-02-20
PRISMA M10 PRE SET (K063183)Gambro Renal Products, Inc.2007-02-15
SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT (K063697)PAJUNK GmbH Medizintechnologie2007-02-14
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE (K063118)C.R. Bard, Inc.2007-02-13
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (K063441)Spire Biomedical, Inc.2007-02-12
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE (K062953)Medisystems Corp.2007-02-12
SPYGLASS IRRIGATION SYSTEM (K063700)Medical Scientific, Inc.2007-02-08
HEMOCATH II (K062901)Med-Conduit, Inc.2007-02-08
NIPRO BIOHOLE NEEDLE (K063368)Nipro Medical Corp.2007-02-05
REPROCESSED TROCARS (K062497)Ascent Healthcare Solutions2007-01-31
SONOTIP II ULTRASOUND NEEDLE SYSTEM (K070129)Medi-Globe Corporation2007-01-31
ENDOGUIDE (K063654)Kms Medical, LLC2007-01-31
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM (K063585)KARL STORZ Endoscopy-America, Inc.2007-01-31
GAMBRO QUICKSET BLOODLINES (K063290)Gambro Renal Products2007-01-30
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (K063431)Spire Biomedical, Inc.2007-01-29
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM (K062918)KARL STORZ Endoscopy-America, Inc.2007-01-17
TROCASYS (K063528)PAJUNK GmbH Medizintechnologie2007-01-17
NIPRO SAFETOUCH II GAMMA (K063721)Nipro Medical Corp.2007-01-12
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR (K061430)Custom Ultrasonics2007-01-12
TRU-CABLE (K063309)Truphatek International, Ltd.2007-01-12
XODUS MEDICAL ANTI-FOG SOLUTION (K063587)Xodus Medical, Inc.2007-01-09
FUSION QUATTRO EXTRACTION BALLOON XL (K063677)Wilson-Cook Medical, Inc.2007-01-05
GAMBRO POSICLEAR (K061782)Gambro Services, Inc.2007-01-04
LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES (K062968)Medsys, S.A.2007-01-03
LITHODIAMOND ULTRA (K061350)Pck Electronic Industry & Trade Co., Ltd.2006-12-22
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES (K062517)Olympus Medical Systems Corporation2006-12-22
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K063446)C.R. Bard, Inc.2006-12-15
NEXUS IRRIGATION TUBING SET (K062551)Nexus Medical, LLC2006-12-15
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (K062922)Chf Solutions, Inc.2006-12-13
CYSTOGLIDE INTRODUCER SHEATH (K052298)Percutaneous Systems, Incorporated2006-12-12
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE (K062707)Innovative Endoscopy Components, LLC2006-12-08
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (K062435)Spire Biomedical, Inc.2006-12-05
TRUEHD (1080P) DIGITAL CAMERA SYSTEM (K063457)Conmed Linvatec2006-12-05
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (K061937)Cook Endoscopy2006-12-01
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 (K063220)Intuitive Surgical, Inc.2006-12-01
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM (K062833)Vidacare Corporation2006-11-30
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (K062340)Cardio-Optics, Inc.2006-11-30
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE (K062399)Rockwell Medical Technologies, Inc.2006-11-17
KARL STORZ VIDEO GASTROSCOPES (K060907)KARL STORZ Endoscopy-America, Inc.2006-11-09
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) (K062671)Kendall2006-11-03
LITHOGOLD (K062081)Tissue Regeneration Technologies, Inc.2006-11-02
SUPERCATH V (K052267)Togo Medikit Co., Ltd.2006-10-27
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM (K061899)Advanced Sterilization Products2006-10-26
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 (K062832)C.R. Bard, Inc.2006-10-20
INTEGRA SL (K062147)Direx Systems Corp.2006-10-20
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 (K062079)Baxter Healthcare Corporation2006-10-19
PRISMA SYSTEM R03.10A (K062090)Gambro Renal Products2006-10-18
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K062786)Given Imaging , Ltd.2006-10-18
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