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Gastroenterology, Urology

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

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RecordFirmDate
MANAN TECHNA-CUT ASPIRATION NEEDLE (K974766)Medical Device Technologies, Inc.1998-01-08
KSEA PLASTIC TROCARS (K974366)Karl Storz Endoscopy1998-01-08
ELECTRODES/PROBES/DEVICES (K974637)Ximed/Prosure/Injectx1998-01-07
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (K970648)Renal Systems, Inc.1998-01-05
S-57 VIDEO IMAGING SYSTEM (K973794)Sopro1998-01-02
S-41 &41S VIDEO IMAGING SYSTEM (K973796)Sopro1998-01-02
S-52 ELECTRONIC VIDEO LAPAROSCOPE (K973795)Sopro1998-01-02
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER (K974048)Hollister, Inc.1997-12-23
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE (K974516)Endolap, Inc.1997-12-22
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE (K974515)Endolap, Inc.1997-12-22
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS (K970708)Terumo Medical Corp.1997-12-19
TELEMED SYSTEMS RETRIEVAL BASKET (K974300)Telemed Systems, Inc.1997-12-19
AMSURE CLEANSING ENEMA SET (K974042)Amsino Intl., Inc.1997-12-19
HYDRA METER (K974127)Automata Instrumentation, Inc.1997-12-19
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES (K973291)Dynamic Technology Corp.1997-12-19
AESOP 3000 SYSTEM AND ACCESSORIES (K972699)Computer Motion, Inc.1997-12-19
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE (K973893)Applied Medical Technologies1997-12-19
BOUSER'S URINAL (K970465)General Polymers1997-12-18
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE (K974164)Medical Device Consultants, Inc.1997-12-18
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 (K974454)Tucson Medical Corp.1997-12-18
COURIER ST BALLOON DILATATION CATHETER (K973008)Boston Scientific Corp1997-12-15
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES (K972280)Wilson Greatbatch Technologies, Inc.1997-12-11
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (K972887)Medline Industries, Inc.1997-12-11
CRIT-LINE MONITOR (CLMIII) (K972470)In-Line Diagnostics Corp.1997-12-11
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM (K972979)Smith & Nephew, Inc.1997-12-11
PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER (K972496)Tao & Tao Technologyt, Inc.1997-12-09
VISTA HEAD MOUNTED DISPLAY (K973436)Vista Medical Technologies, Inc.1997-12-09
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY (K974158)Ortho Development Corp.1997-12-09
SPHINCTEROTOME (K973826)Boston Scientific Corp1997-12-05
S-357 VIDEO IMAGING SYSTEM (K973798)Sopro1997-12-03
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (K973611)Spectrascience, Inc.1997-12-02
CURVILINEAR SUTURE PLACEMENT SYSTEM (K973415)Laurus Medical Corp.1997-12-02
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP (K973313)Innovasive Devices, Inc.1997-12-01
THE AUTO SUTURE* MIBB** SYSTEM (K973496)United States Surgical, A Division of Tyco Healthc1997-12-01
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST (K964539)Zyzatech Water Systems, Inc.1997-11-26
BELZER-MPS (K972066)Trans-Med Corp.1997-11-26
ENDOASSIST (K973249)Armstrong Healthcare , Ltd.1997-11-26
NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS (K972206)Nipro Medical Corp.1997-11-26
COBRA HAND PIECE (K973366)Vidamed, Inc.1997-11-26
D.O.R.C. HEXON ILLUMINATION SYSTEM (K973229)Dutch Ophthalmic USA, Inc.1997-11-25
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM (K973359)Richard Wolf Medical Instruments Corp.1997-11-24
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER (K963933)Baxter Healthcare Corp1997-11-24
WILSON-COOK STRICTURE MEASURING CATHETER (K973205)Wilson-Cook Medical, Inc.1997-11-24
KARL STORZ DIRECT COUPLED CAMERA HEAD (K973252)Karl Storz Imaging, Inc.1997-11-24
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) (K973558)Ultracell Medical Technologies, Inc.1997-11-24
URESIL GUIDEWIRE (K972582)Uresil Corp.1997-11-21
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT (K973232)Olympus Winter & Ibe GmbH1997-11-21
KNOTT NG TUBE (K971354)Michael M. Knott, M.D.1997-11-19
G.E.M. WATER SYSTEMS, INTERNATIONAL (K970674)G.E.M. Water Systems1997-11-19
SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR (K973293)Vaughan Weeks1997-11-18
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK (K973290)Vaughan Weeks1997-11-14
RESTORE (A.K.A. CAPSURE) (K971359)Nebl, Inc.1997-11-14
ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR (K973139)Ethicon Endo-Surgery, Inc.1997-11-13
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (K970661)Baxter Healthcare Corp1997-11-12
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970654)Baxter Healthcare Corp1997-11-12
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM (K973113)Boston Scientific Corp1997-11-10
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (K973546)Kendall Healthcare Products Co. Div.Of Tyco Health1997-11-07
D.O.R.C. SOLUX LIGHT SOURCE (K973757)Dutch Ophthalmic USA, Inc.1997-11-07
LOW PROFILE FEEDING SET ACCESSORY (K971757)Applied Medical Technologies1997-11-07
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE (K962554)Abbott Laboratories1997-11-07
KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING (K973068)Karl Storz Endoskop GmbH1997-11-07
ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR (K972927)Richard Wolf Medical Instruments Corp.1997-11-06
STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM (K973215)Laurus Medical Corp.1997-11-06
CONVEEN EASICATH SET (K973070)Coloplast Corp.1997-11-06
AVE BRIDGE STENT SYSTEM (K971295)Arterial Vascular Engineering, Inc.1997-11-05
ERCO-VAC (K972537)Ercons, Inc.1997-11-03
QUICK-CARE BIOPSY NEEDLE (K973565)Cook, Inc.1997-11-03
TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 (K970482)Srs Intl.1997-10-31
ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (K973253)International Medical Products, Inc.1997-10-30
HX-20/21-1 ENDOSCOPIC LIGATOR (K964661)Olympus America, Inc.1997-10-30
LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE (K972984)Lerner Medical, Inc.1997-10-29
ERCO-RIBBON (K972353)Ercons, Inc.1997-10-28
COMBIPORT FLUID LAVAGE DEVICE (K971259)B.Braun Medical, Inc.1997-10-27
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET (K971313)National Medical Care, Inc.1997-10-27
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (K970595)Circon Video1997-10-24
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES (K972471)Smith & Nephew, Inc.1997-10-24
TRI TALON RETRIEVAL FORCEPS (K973071)Medical Engineering Laboratory, Inc.1997-10-24
AHCS HEMOPERFUSION SYSTEM (K971015)American Health Care Systems, Inc.1997-10-22
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) (K971897)Medron, Inc.1997-10-21
FEMASSIST URINARY DEVICE (K963858)Insight Medical Corp.1997-10-21
BARD RAPIDFIRE MULTIPLE BAND LIGATOR (K971137)C.R. Bard, Inc.1997-10-16
BARD ENDOSCOPIC OVERTUBE (#000307) (K973500)C.R. Bard, Inc.1997-10-16
REJOYN PENILE SUPPORT SYSTEM (K971576)American Medtech1997-10-16
INSULATOR WIRE GUIDE (K972977)Cook Urological, Inc.1997-10-10
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (K972964)Atrion Medical Products, Inc.1997-10-10
MRI COMPATIBLE BIOPSY NEEDLES (K962977)Manan Medical Products, Inc.1997-10-09
CRE BALLOON DILATATION CATHETER (K971320)Boston Scientific Corp1997-10-09
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE (K972926)KARL STORZ Endoscopy-America, Inc.1997-10-08
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB (K972825)Cordis Corp.1997-10-07
RUSCH BRILLANT BALLOON CATHETER (K971643)Rusch Intl.1997-10-07
VTU-1 VACUUM ERECTION SYSTEM (K971257)Mckenna & Cuneo1997-10-03
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE (K972578)Ethicon Endo-Surgery, Inc.1997-10-01
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE (K972579)Baxter Healthcare Corp1997-10-01
ORIGIN LIGATOR DEVICE (K972685)Origin Medsystems, Inc.1997-10-01
ASAHI AM-R SERIES DIALYZERS (K970650)Asahi Medical Co., Ltd.1997-09-30
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET (K972731)Klein-Baker Medical, Inc.1997-09-29
RELIANT CHARGER (K971768)Walling Medical Equipment Co.1997-09-29
JIMMY JOHN III RECTAL NOZZLE (K973256)Colon Therapeutics1997-09-29
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET (K970253)Gambro Healthcare1997-09-26
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) (K970937)Mist, Inc.1997-09-26
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