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Gastroenterology, Urology

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

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RecordFirmDate
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K994068)Cordis Corp.1999-12-23
DUCPREP BREAST ASPIRATOR, MODEL PMPO2 (K993342)Windy Hill Technology, Inc.1999-12-23
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER (K993651)Sc Hennig Enterprises Europe Srl1999-12-23
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH (K992402)Telemed Systems, Inc.1999-12-22
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD (K992390)Telemed Systems, Inc.1999-12-22
SPACE-OR RETRACTOR (K993544)Advanced Surgical Concepts (Asc)1999-12-22
BIOTEQUE A.V. FISTULA NEEDLE SET (K993118)Bioteque Corp.1999-12-17
TRIP TONOMETRY CATHETER, 14F (K993296)Datex-Ohmeda, Inc.1999-12-15
AED CYSTOSCOPE (K993689)National Advanced Endoscopy Devices, Inc.1999-12-15
CUSTODIOL (K992209)Dr. Franz Kohler Chemie GmbH1999-12-10
BARDEX I.C. PEDIATRIC FOLEY CATHETER (K993464)C.R. Bard, Inc.1999-12-10
ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES (K993103)Richard Wolf Medical Instruments Corp.1999-12-10
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 (K993226)Memcath Technologies, LLC1999-12-10
RUSCH BRILLANT SILICONE FOLEY (K993063)Rusch Intl.1999-12-09
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 (K990643)Althin Medical AB an Affiliate of Baxter Intl1999-12-07
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE (K984168)United States Endoscopy Group, Inc.1999-12-07
AED LAPAROSCOPE (K993688)National Advanced Endoscopy Devices, Inc.1999-12-06
MANUAL BONE MARROW BIOPSY DEVICE (K993435)Promex, Inc.1999-12-06
OMNISONIC ENDOSCOPIC DEFLECTOR (K993445)Omnisonics Medical Technologies1999-12-06
CKHEMO, MODEL CKHEMO VERSION 1.0 (K992255)Csam, Inc.1999-11-30
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES (K993721)Laborie Medical Tech Corp.1999-11-29
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K993646)Cordis Corp.1999-11-28
PBN DILATORS (K990808)Medical Device Technologies, Inc.1999-11-26
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 (K992894)Baxter Healthcare Corp1999-11-24
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (K993046)Fibra Sonics, Inc.1999-11-22
SUTURE CLINCH (K992852)Applied Medical Resources1999-11-22
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT (K992813)Ethicon Endo-Surgery, Inc.1999-11-18
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS (K983239)Rasco1999-11-18
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, (K993588)Guidant Corp.1999-11-17
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM (K992793)Better Water, Inc.1999-11-16
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN (K991320)Medical Components, Inc.1999-11-10
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 (K992713)Medtronic Functional Diagnostics A/S1999-11-10
COLDLIGHTSOURCE PL3000 (K993300)Fiber Imaging Technologies, Inc.1999-11-05
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 (K990229)Justec Medical Products, Inc.1999-11-04
OLYMPUS NA-10J-KB ASPIRATION NEEDLE (K991672)Olympus America, Inc.1999-11-03
PALMAZ XL TANSHEPATIC BILIARY STENTS (K993091)Cordis Corp.1999-10-29
NUTRISAFE EXTENSION TUBE (K991918)Vygon Corp.1999-10-29
SHELLY PROTECTED AV FISTULA NEEDLE (K992653)Diasol, Inc.1999-10-27
BARIATRIC LAPAROSCOPE, MODEL 367 (K993045)Stryker Endoscopy1999-10-27
DRYASOL ACID CONCENTRATE MIX (K993212)Diasol, Inc.1999-10-22
MEDTRONIC AVE BRIDGE STENT (K993145)Medtronic Ave, Inc.1999-10-21
50 W METAL HALIDE ILLUMINATOR, VES 0501. (K992447)Angiolaz, Inc.1999-10-20
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (K993138)Ballard Medical Products1999-10-20
KSEA SCBCOM (K992469)Karl Storz Endoscopy1999-10-15
MODIFICATION TO INTRASTENT (K992816)Intratherapeutics, Inc.1999-10-15
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232 (K992612)Ethicon Endo-Surgery, Inc.1999-10-14
URETERO-RENOSCOPE (K992527)Fiber Imaging Technologies, Inc.1999-10-13
NEO-2 METER (K992431)Automata Instrumentation, Inc.1999-10-13
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM (K992319)Guidant Corp.1999-10-08
BAHO AUTOCLAVABLE CYSTOSCOPE (K992983)Innovative Endoscopy Components, LLC1999-10-07
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (K993064)Gambro Renal Care Products1999-10-06
V.T.S., INC. (V.T.-3) (K992442)Vts, Inc.1999-10-05
OLYMPUS WORKING ELEMENT FOR PROBES (K992141)Olympus Winter & Ibe GmbH1999-09-29
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C (K990500)The Kendal Co.1999-09-28
A-15 HEMODIALYZER (K992594)Althin Medical AB1999-09-24
CORE AUDIBLE TROCAR II (K992250)Core Dynamics, Inc.1999-09-24
A-18 HEMODIALYZER (K992565)Althin Medical AB1999-09-23
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 (K984358)Olympus America, Inc.1999-09-17
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE (K992755)Cordis, A Johnson & Johnson Co.1999-09-15
SCHOELLY RIGID ENDOSCOPES (K992437)Fiber Imaging Technologies, Inc.1999-09-14
LUMENON XENON LIGHT SOURCE (K992050)Walter Lorenz Surgical, Inc.1999-09-14
XENON LIGHT SOURCE PES 1 (K992540)Laser Optik Systeme GmbH & Co. KG1999-09-14
BARD BALLOON INFLATION SYSTEM (K991375)C.R. Bard, Inc.1999-09-10
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) (K992196)Hemocleanse, Inc.1999-09-10
FRESENIUS BLOOD VOLUME MONITOR (K982926)Fresenius Medical Care North America1999-09-03
UROLOGICAL CATHETER (K992137)Apogee, Inc.1999-09-03
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 (K990867)Advanced Cardiovascular Systems, Inc.1999-09-02
CORE POUCH (K992190)Core Dynamics, Inc.1999-09-01
ENDIUS SUCTION/IRRIGATION INSTRUMENT (K992535)Endius, Inc.1999-09-01
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE (K974387)Microwave Medical Systems, Inc.1999-09-01
INTRASTENT II (K990592)Intratherapeutics, Inc.1999-09-01
MEDTRONIC AVE BRIDGE STENT (K992569)Medtronic Ave, Inc.1999-08-31
MEDIFIX INC. (K992483)Medifix, Inc.1999-08-30
JMS APHERESIS NEEDLE (K990510)Jms Co., Ltd.1999-08-30
JMS A. V. FISTULA NEEDLE SET (K990470)Jms Co., Ltd.1999-08-30
RENACLEAR DIALYZER CLEANING SYSTEM (K991851)Minntech Corp.1999-08-30
TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS (K990785)Jakoubek Medizintechnik GmbH1999-08-27
THERMOFLEX SYSTEM (K991847)Argomed, Inc.1999-08-26
FLEXIFLO ENTERAL FEEDING TUBE (K992494)Ross Product Div. Abbott Laboratories1999-08-25
TRIP TONOMETRY CATHETER, 8F (K992181)Datex-Ohmeda, Inc.1999-08-24
ROTOSNARE (K992477)Inscope, LLC1999-08-24
THE 3PM EGG MACHINE (DEN990005)3pm Co., Inc.1999-08-20
FUNNEL TROCAR (K992324)Patton Medical Corp.1999-08-19
LAPAROCAM (K992541)Karl Storz Endoscopy1999-08-19
UROSURGE SPIRALFLO URETERAL STENT (K992391)Urosurge, Inc.1999-08-18
KSEA CALCUSPLIT (K992114)Karl Storz Endoscopy1999-08-18
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (K992006)Integra Neurocare, LLC1999-08-17
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, (K991980)Ethicon Endo-Surgery, Inc.1999-08-17
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES (K990724)Conway Stuart Medical, Inc.1999-08-13
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK (K984546)Hemocleanse, Inc.1999-08-13
OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D (K991718)Richard Wolf Medical Instruments Corp.1999-08-12
GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE (K992499)Gallini U.S., LLC1999-08-12
DRAINAGE BAG (K990428)Remington Medical, Inc.1999-08-12
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS (K991674)Cordis Corp.1999-08-12
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA (K991623)Nipro Medical Corp.1999-08-09
UROSTYM BIOFEEDBACK AND STIMULATION PROBES (K990041)Laborie Medical Tech Corp.1999-08-05
MAHE INSTRUMENTS (K991426)Mahe Intl., Inc.1999-08-05
FLEXISCOPE IQ 101 (K992362)Schoelly Fiberoptic GmbH1999-08-05
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS (K991594)Sangstat Medical Corp.1999-08-05
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE (K983618)Rockwell Medical Technologies, Inc.1999-08-05
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