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Gastroenterology, Urology

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

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RecordFirmDate
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM (K140753)Medivators2014-07-15
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS (K140101)Ab Medica Sas2014-07-10
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K134005)Intromedic Co., Ltd.2014-07-09
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY (K133299)Fresenius Medical Care, North America - Renal Ther2014-07-07
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU (K141051)Arrow International, Inc.2014-07-07
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM (K133110)Boston Scientific Corporation2014-07-02
MIROCAM CAPSULE ENDOSCOPE SYSTEM (K140751)Intromedic Co., Ltd.2014-06-30
CONSURE STOOL MANAGEMENT SYSTEM (K133465)Consure Medical Pvt , Ltd.2014-06-26
ABBVIE PEG (K133087)AbbVie , Inc.2014-06-19
ABBVIE NJ (K133129)AbbVie , Inc.2014-06-19
ABB VIE J (K133096)AbbVie , Inc.2014-06-18
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER (K141363)Merit Medical Systems, Inc.2014-06-18
BI-FLEX URETERAL ACCESS SHEATH (K140441)Promepla Sam2014-06-17
WIJAY EZ-VOID EXTERNAL CATHETER VALVE (K140562)Leomed, LLC2014-06-16
NXSTAGE EXPRESS FLUID WARMER (K140623)Nxstage Medical, Inc.2014-06-16
BONASTENT BILIARY (K140760)Endochoice, Inc.2014-06-16
PILLING ESOPHAGEAL BOUGIES (K133439)Teleflexmedical, Inc.2014-06-16
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG (K132375)Genicon2014-06-12
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM (K141250)KARL STORZ Endoscopy-America, Inc.2014-06-11
FLEX ENDOSCOPIC INSTRUMENTS (K140662)Design Standards Corp.2014-06-11
GUARDIAN URETHRAL SHEATH (K141252)Solace Therapeutics2014-06-09
ENDOWRIST VESSEL SEALER (K140189)Intuitive Surgical, Inc.2014-06-05
VTI SUCTION IRRIGATION SYSTEM (K141323)Regulatory Technology Services, LLC2014-06-04
MED-RX ORAL/ENTERAL SYRINGE (K131183)Benlan, Inc.2014-06-03
SHERPA PAK TRANSPORTER (K133694)Paragonix Technologies, Inc.2014-05-23
WALLFLEX BILIARY RX STENT SYSTEM (K140630)Boston Scientific2014-05-23
NXSTAGE SYSTEM ONE (K140526)Nxstage Medical, Inc.2014-05-19
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM (K133763)Medi-Globe Corporation2014-05-15
NXSTAGE PUREFLOW SL (K140571)Nxstage Medical, Inc.2014-05-15
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS (K133700)Boston Scientific Corporation2014-05-14
VERSACUT + TISSUE MORCELLATOR (K133272)Lumenis, Ltd.2014-05-13
BIOMARC COAXIAL NEEDLE (K133148)Carbon Medical Technologies, Inc.2014-05-13
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (K132686)Degania Silicone , Ltd.2014-05-12
SINGLE-SITE PORT (K133203)Intuitive Surgical, Inc.2014-05-09
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM (K133251)C.R. Bard, Inc.2014-05-09
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM (K132475)Fluoptics2014-05-07
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM (K133149)Mar Cor Purification, Inc.2014-04-30
SPLIT CATH RG (K130889)Medcomp2014-04-28
MONOFILAMENT POLYPECTOMY SNARE (K140763)United States Endoscopy2014-04-24
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) (K140561)Xlumena, Inc.2014-04-23
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF (K133829)Vivonic GmbH2014-04-22
HC-1 AND HC-1 CLASSIC (K131852)Transcendencias Comerciales SL Transcom2014-04-17
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES (K131962)Intuitive Surgical, Inc.2014-04-17
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION (K133783)Ameriwater2014-04-16
ELISIO-H HEMODIALYZER (K140191)Nipro Medical Corporation2014-04-14
REVEEL ENDOSCOPIC RETRACTOR (K133345)Retraction Limited2014-04-11
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) (K131902)Pentax Medical Company2014-04-10
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY (K123555)Covidien2014-04-09
PENTAX VIDEO COLONOSCOPES (EC FAMILY) (K131855)Pentax Medical Company2014-04-09
MANDREL GUIDEWIRE (K140482)Lake Region Medical2014-04-08
US ENDOSCOPY DISTAL ATTACHMENT CAP (K140315)United States Endoscopy Group, Inc.2014-04-04
BARD RITECATH INTERMITTENT CATHETER (K133470)C.R. Bard, Inc.2014-04-04
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X (K131202)Dialysis Medical Solutions, LLC2014-04-03
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER (K133933)Boston Scientific Corporation2014-04-02
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861)Intuitive Surgical, Inc.2014-03-28
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT (K133807)Gambro Renal Products, Inc.2014-03-26
CORGRIP (K133599)Corpak Medsystems2014-03-26
SAFETY BIOPSY NEEDLE SYSTEM (K140137)Pfm Medical, Inc.2014-03-25
SRS ENDOSCOPIC STAPLING SYSTEM (K132151)Medigus , Ltd.2014-03-19
SEAL SINGLE-USE BIOPSY VALVE (K133734)Endochoice, Inc.2014-03-19
TORRENT IRRIGATION SYSTEM (K140405)United States Endoscopy Group, Inc.2014-03-12
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM (K130981)Cordis Corp.2014-03-12
NAVIGATOR HD URETERAL ACCESS SHEATH SETS (K140323)Boston Scientific2014-03-07
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT (K134026)Olympus Medical Systems Corp.2014-03-07
LIGHTHOUSE URINARY CATHETER (K140099)Seedings Life Science Ventures, LLC2014-03-04
NXSTAGE SYSTEM ONE WITH NXVIEW (K133547)Nxstage Medical, Inc.2014-03-03
PRESTO BREAST BIOPSY DEVICE (K133702)Sontina Medical, LLC2014-02-28
ANAL RECTAL OVERTUBE (K131598)United States Endoscopy Group, Inc.2014-02-26
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED (K132389)Daniel & Daniel Consulting2014-02-25
E-Z CHECK OZONE TEST STRIPS (K132344)Reprocessing Products Corporation (Rpc)2014-02-25
INTONEMV (K134020)Incontrol Medical, LLC2014-02-25
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER (K133615)Well Lead Medical Co., Ltd.2014-02-24
SHERPA PAK CARDIAC TRANSPORT SYSTEM (K133432)Paragonix Technologies, Inc.2014-02-21
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT (K133948)Bard Peripheral Vascular, Inc.2014-02-21
MEDLINE BIOPSY VALVE (K131426)Medline Industries, Inc.2014-02-21
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (K133076)Neometrics, Inc.2014-02-20
8MM TROCAR KIT (K133845)Intuitive Surgical2014-02-19
NMI DIALYSIS CATHETER (K131260)Navilyst Medical, Inc.2014-02-14
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (K132192)Bracco Diagnostic, Inc.2014-02-14
METRIXCARE (K132424)The Metrix Company2014-02-12
ENDORINGS (K133359)Endo-Aid, Inc.2014-02-11
CITRISOL ACID CONCENTRATE (K130511)Diasol, Inc.2014-02-10
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES (K130616)Biopsybell S.R.L.2014-02-07
FUSE 1C COLONOSCOPY SYSTEM (K132839)Endochoice, Inc.2014-02-06
STREAMLINE EXPRESS (K132602)Nxstage Medical, Inc.2014-02-04
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), (K133796)Marvao Medical Devices, Ltd.2014-01-31
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (DEN120023)Given Imaging , Ltd.2014-01-29
MACY CATHETER (K133881)Hospi Corporation2014-01-24
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES (K133987)Boston Scientific Corporation2014-01-24
REPROCESSED CLOSURE SYSTEM (K133414)Sterilmed, Inc.2014-01-22
INJECTION NEEDLE (K132065)Endochoice, Inc.2014-01-17
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR (K133375)Banyan Medical, LLC2014-01-17
SUPRAPUBIC CATHETER AND INTRODUCER SET (K132890)Mediplus , Ltd.2014-01-17
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE (K130674)Xeridiem Medical Devices2014-01-13
FUJIFILM 600 SERIES ENDOSCOPES (K132210)Fujifilm Medical Systems U.S.A, Inc.2014-01-10
CASCADE HEMODIALYSIS/APHERESIS CATHETER (K130851)Health Line International Corporation2014-01-09
OCCLUDER OCCLUSION BALLOON CATHETER (K133750)Boston Scientific Corporation2014-01-08
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM (K133747)Endochoice, Inc.2014-01-08
ENDOSCOPIC SUTURE CUTTER (K133736)United States Endoscopy Group, Inc.2014-01-07
INTONEMV (K133826)Incontrol Medical, LLC2014-01-06
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