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Gastroenterology, Urology

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

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RecordFirmDate
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 (K990050)Richard Wolf Medical Instruments Corp.1999-03-26
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS (K990687)Olympus Optical, Co.1999-03-26
WILSON-COOK BIPOLAR PROBE (K990145)Wilson-Cook Medical, Inc.1999-03-25
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP (K990456)Hollister, Inc.1999-03-25
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C (K990072)Cook Urological, Inc.1999-03-25
HERMES OPERATING ROOM CONTROL CENTER (K990691)Computer Motion, Inc.1999-03-23
KSEA ENDOSCOPE HOLDER (K990334)KARL STORZ Endoscopy-America, Inc.1999-03-22
MOSS GASTROSTOMY TUBE (K990389)Moss Tubes, Inc.1999-03-22
GILTECH PLUS CONNECTING TUBE SET (K983624)Giltech Plus, Inc.1999-03-18
MODIFICATION OF MOSS P.E.G. TRAY (K984628)Moss Tubes, Inc.1999-03-17
MEDIVISION LAPAROSCOPE (K984434)Medivision Scope Service Center, Inc.1999-03-17
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO (K990765)Flexmedics1999-03-15
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (K983126)Minntech Corp.1999-03-08
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX (K984607)Richard Wolf Medical Instruments Corp.1999-03-05
RESTORE (AKA RE/STOR) (K983164)Nebl, Inc.1999-03-05
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES (K990379)Dexide, Inc.1999-03-04
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 (K983075)Guidant Corp.1999-03-03
MOSS TUBES, INC. NASAL TUBE - MARK IV (K984629)Moss Tubes, Inc.1999-03-02
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES (K983476)Navion Biomedical Corp.1999-03-01
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 (K981125)Medical Components, Inc.1999-02-26
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE (K984310)Moss Tubes, Inc.1999-02-24
ERCO-RIBBON -C (K990008)Ercons, Inc.1999-02-24
ERCO-VAC -C (K990006)Ercons, Inc.1999-02-24
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) (K980386)Gambro Healthcare1999-02-24
BARDEX LUBRI-SIL I.C. FOLEY CATHETER (K984136)Bard Medical Div.1999-02-16
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY (K982333)Cook, Inc.1999-02-12
WILSON-COOK PANCREATIC WEDGE STENT (K990130)Wilson-Cook Medical, Inc.1999-02-12
SELF CATH SET/SAFETY CATH (K983010)Rusch Intl.1999-02-12
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) (K990127)Corpak Medsystems1999-02-10
POTENCY TEST STRIPS, INDICATOR TEST STRIPS (K974426)Reprocessing Products Corp1999-02-10
MAX IT (K983438)Dorea, Inc.1999-02-08
VIRILIS PENILE PROSTHESIS (K983015)Specialty Surgical Products, Inc.1999-02-05
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (K981733)Medtronic Functional Diagnostics A/S1999-02-04
NUTRISAFE ENTERAL FEEDING TUBE (K981629)Schiff & Co.1999-02-04
BARDEX LUBRI-SIL FOLEY CATHETER (K984084)Bard Medical Div.1999-02-01
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM (K982346)AngioDynamics, Inc.1999-01-29
CHAIT CECOSTOMY CATHETER (K982500)Cook, Inc.1999-01-27
MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE (K983527)Dofi Technologies, Inc.1999-01-19
OLYMPUS HX-20 SERIES LIGATING DEVICE (K984255)Olympus Corp of America1999-01-12
INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 (K984444)Sandhill Scientific, Inc.1999-01-11
3-CHIP VIDEO CAMERA (K983566)Stryker Endoscopy1999-01-11
JMS DIALYZER PRIMING SET (K983707)Jms Co., Ltd.1999-01-08
IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM (K983567)Med Images, Inc.1999-01-07
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS (K981680)Dayton Water Systems1998-12-31
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER (K982337)Haidylena Medical Egypt1998-12-29
UNIPOLAR OPTICAL BIOPSY FORCEPS (K983811)Olympus Winter & Ibe GmbH1998-12-24
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR (K983559)Icu Medical, Inc.1998-12-24
TRIP TONOMETRY CATHETER, 16F (K983366)Datex-Engstrom, Inc.1998-12-23
SOLARTEC SOURCE 270, MODEL # 90123 (K983714)Cogent Light Technologies, Inc.1998-12-23
MODULAP (K983623)Atc Technologies, Inc.1998-12-18
CORDIS NITINOL STENT AND DELIVERY SYSTEM (K980823)Cordis Corp.1998-12-18
DCI ENDOSCOPE (K983363)KARL STORZ Endoscopy-America, Inc.1998-12-18
FUJINON EVL-F VIDEO LAPROSCOPE (K983561)Fujinon, Inc.1998-12-16
AUTO SUTURE LAPAROSCOPES DEVICE (K983293)United States Surgical, A Division of Tyco Healthc1998-12-16
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE (K983498)C.R. Bard, Inc.1998-12-15
INJECTION NEEDLE PROBE/DEVICE-TUNIS (K983765)Ximed/Prosure/Injectx1998-12-11
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 (K983628)Richard Wolf Medical Instruments Corp.1998-12-11
ULTRACON ULTRAFILTRATOR (K981253)Interpore Intl.1998-12-11
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE (K983187)Medsol Corp.1998-12-10
MICRO X RESIDUAL TEST STRIPS (K974064)Reprocessing Products Corp1998-12-07
RAPPORT V.T.D. (K982275)Owen Mumford USA, Inc.1998-12-04
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE (K983279)Richard Wolf Medical Instruments Corp.1998-12-02
DELIVERY SHEATH (K983415)Conway Stuart Medical, Inc.1998-12-01
MEDISYSTEMS TRANSDUCER PROTECTOR (K983076)Medisystems Corp.1998-11-25
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (K981365)Sherwood Medical Co.1998-11-25
PERIPHERAL AVE STENT SYSTEM (K983008)Peripheral Ave1998-11-25
ERCO-RIBBON (K981343)Ercons, Inc.1998-11-24
IN-PROBE II URODYNAMIC SYSTEM (K983325)Influence, Inc.1998-11-24
ERCO-VAC (K981357)Ercons, Inc.1998-11-24
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) (K980492)Circon Acmi1998-11-17
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K980182)Usfilter/Ionpure, Inc.1998-11-16
NIR BILIARY STENT (K973171)Medinol, Ltd.1998-11-13
HEMOCOR HPH 700 HEMOCONCENTRATOR (K983085)Minntech Corp.1998-11-13
DIAPACT CRRT (K973322)B.Braun Medical, Inc.1998-11-10
NATURALYTE, MODEL # 08-4004-1 (K982813)Kaybath, Inc.1998-11-06
MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY (K983538)Solos Endoscopy, Inc.1998-11-06
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE (K983218)Avid N.I.T., Inc.1998-11-06
INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS) (K980129)Richard Wolf Medical Instruments Corp.1998-11-05
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET (K982760)Gambro Healthcare1998-11-04
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (K983101)C.R. Bard, Inc.1998-11-03
SMALL VAGINAL/RECTAL ELECTRODE (K983206)Empi1998-11-03
POS-T-VAC (AVP-1000) (K983245)Pos-T-Vac, Inc.1998-11-02
POS-T-VAC (IVP-600) (K983246)Pos-T-Vac, Inc.1998-11-02
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER (K982970)Mri Manufacturing and Research, Inc.1998-10-28
ADVANCED UROSCIENCE INJECTION NEEDLE (K982890)Advanced Uroscience, Inc.1998-10-26
MGB LAPALUX TELESCOPE (K982013)Mgb Endoskopische Gerate GmbH1998-10-21
FLEXIMA (K982508)Boston Scientific Corp1998-10-16
MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (K982412)In-Line Diagnostics Corp.1998-10-09
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE (K981323)Novartis Nutrition Corp.1998-10-09
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT (K981591)International Regulatory Consultants1998-10-09
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP (K982417)Innerdyne, Inc.1998-10-07
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO (K980906)Transonic Systems, Inc.1998-10-06
OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE (K982734)The Olympus Optical Co.1998-10-05
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE (K982905)Karl Storz Endoscopy1998-10-05
MEDIVISION CYSTOSCOPE (K982620)Medivision Scope Service Center, Inc.1998-09-30
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM (K982623)Aesculap, Inc.1998-09-30
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES (K981940)Dexide, Inc.1998-09-25
XENON LIGHT SOURCE, MODELS LS6180, LS6035 (K982962)Contec Medical Vision, Ltd.1998-09-23
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H (K974899)Gambro Healthcare1998-09-23
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT (K982960)Medical Device Technologies, Inc.1998-09-23
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