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Gastroenterology, Urology

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

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RecordFirmDate
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES (K991028)Cordis Corp.1999-08-04
INTRASTENT (K991929)Intratherapeutics, Inc.1999-08-04
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS (K992275)Fresenius USA, Inc.1999-08-04
MEDTRONIC AVE BRIDGE STENT (K992318)Medtronic Ave, Inc.1999-08-02
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE (K990854)Innerdyne, Inc.1999-08-02
CRIT-LINE MONITOR III (CLM III) (K992227)In-Line Diagnostics Corp.1999-07-30
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION (K991520)Fresenius Medical Care North America1999-07-30
AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE (K992288)Tyco Intl. (Us), Inc.1999-07-30
BLUNT TIP TROCAR PORT (K992353)Origin Medsystems, Inc.1999-07-30
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION (K991533)Peripheral Ave1999-07-29
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (K991512)Asahi Medical Co., Ltd.1999-07-29
SWISS LITHOCLAST MULTIPURPOSE PROBE (K992251)Electro Medical Systems SA1999-07-27
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) (K991668)Novartis Nutrition Corp.1999-07-26
ENDOSCOPIC CAMERA (K991416)Genzyme Surgical Product (Genzyme Biosurgery)1999-07-20
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 (K991389)Medtronic Functional Diagnostics A/S1999-07-15
SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 (K991382)Genicon, LC1999-07-15
ELECTRO MECHANICAL LITHOTRIPTOR (K990341)Northgate Technologies, Inc.1999-07-14
SMITH & NEPHEW SUTURE LOK (K991500)Smith & Nephew Endoscopy, Inc.1999-07-14
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY (K982326)Boston Scientific Corp1999-07-12
TROCAR SYSTEM ACCORDING TO HASSON (K990237)Olympus America, Inc.1999-07-12
VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE (K991303)Vista Medical Technologies, Inc.1999-07-12
OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER (K991377)Omnisonics Medical Technologies1999-07-12
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (K991323)Smith & Nephew, Inc.1999-07-06
DD URETERAL STENT, INTEGRAL STENT (K982974)Rusch Intl.1999-07-02
COAGULOOP (K991314)American Medical Systems, Inc.1999-06-29
GYRUS ENDOUROLOGY SYSTEM (K990628)Gyrus Medical , Ltd.1999-06-29
DAUM MRI/CONVENTIONAL BIOPSY KIT (K991366)Daum GmbH1999-06-25
HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY). (K991444)Computer Motion, Inc.1999-06-25
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM (K991793)AngioDynamics, Inc.1999-06-25
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS (K991928)Allegiance Healthcare Corp.1999-06-25
ASH ADVANTAGE PERITONEAL CATHETER (K991042)Janin Group, Inc.1999-06-25
DCI ENDOSCOPE (K991228)Karl Storz Endoscopy1999-06-23
DCI ENDOSCOPE (K991171)Karl Storz Endoscopy1999-06-23
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS (K991005)Dayspring Medical, Inc.1999-06-22
IMPACT BALLOON DILATION CATHETER (K983373)B. Braun/Mcgaw1999-06-22
C-FLEX URETERAL STENTS (K991219)Applied Medical Resources1999-06-21
GENYX MEDICAL INJECTION NEEDLE (K990996)Genyx Medical, Inc.1999-06-18
RENAL LINK (K990953)Baxter Healthcare Corp1999-06-18
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 (K990864)Boston Scientific Corp1999-06-11
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 (K991178)Richard Wolf Medical Instruments Corp.1999-06-11
COOPERSURGICAL INFRARED COAGULATOR (K990852)CooperSurgical, Inc.1999-06-11
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT (K980438)Medical Components, Inc.1999-06-10
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER (K991734)Computer Motion, Inc.1999-06-09
MTP EXTRACTION BAG (K990912)Mtp Medical Technical Promotion GmbH1999-06-09
FUJI CATHETER, MODEL CTH001 (K983867)Windy Hill Technology, Inc.1999-06-09
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI (K991003)Dayspring Medical, Inc.1999-06-09
MTP UROPUMP DISPOSABLE TUBING SET (K990909)Mtp Medical Technical Promotion GmbH1999-06-09
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH (K983511)Medical Components, Inc.1999-06-08
DISTENDER SERIES II BAROSTAT (K991288)G & J Electronics, Inc.1999-06-08
AUTO SUTURE ABBI SYSTEM (K983296)United States Surgical, A Division of Tyco Healthc1999-06-04
STRYKER INFRAVISION ESOPHAGEAL KIT (K983220)Stryker Endoscopy1999-06-04
GASTRIC AND RECTAL CATHETERS (K973844)G & J Electronics, Inc.1999-06-04
METRA PS PROCEDURE KIT (K984600)Inlet Medical, Inc.1999-06-03
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL (K990850)CooperSurgical, Inc.1999-06-01
INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 (K990663)Medtech , Ltd.1999-05-27
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM (K991703)Stryker Instruments1999-05-27
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K991635)Computer Motion, Inc.1999-05-27
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT (K991431)Arrow Intl., Inc.1999-05-26
TRU-CORE I REUSABLE BIOPSY INSTRUMENT (K990839)Medical Device Technologies, Inc.1999-05-20
GALLINI ATRA-CUT NEEDLE (K990645)Gallini U.S., LLC1999-05-19
ETB TROCAR SYSTEM (K990894)The Altomec Corp.1999-05-19
VISTA STEREOSCOPE SYSTEM (K990635)Vista Medical Technologies, Inc.1999-05-19
EASTGATE PERSONAL MONITOR (K990731)Eastgate Trading Corp.1999-05-19
INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE (K990493)Innerdyne, Inc.1999-05-18
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT (K984022)Arrow Intl., Inc.1999-05-18
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 (K990509)Implemed, Inc.1999-05-18
MANOMETRIC ASSEMBLIES (K983665)Dentsleeve Pty., Ltd.1999-05-17
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- (K983720)Asahi Medical Co., Ltd.1999-05-17
JACKSON ESOPHAGEAL DILATOR (K990935)Pilling Weck Surgical1999-05-17
GALLINI BYCUT NEEDLE (K990716)Gallini U.S., LLC1999-05-17
MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM (K990515)International Medical Systems1999-05-13
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 (K990441)Sandhill Scientific, Inc.1999-05-12
ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER (K990507)Althin Biopharm, Inc.1999-05-07
CYSTIC DUCT BALLOON DILATING CATHETER (K983154)Applied Medical Resources1999-05-05
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (K990376)Ballard Medical Products1999-05-03
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 (K991032)Guidant Corp.1999-04-30
EXTRACORPOREAL BLOOD CIRCUIT (K982340)Haidylena Medical Egypt1999-04-30
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC (K990631)Cordis Corp.1999-04-30
HP M2376A DEVICE LINK SYSTEM (K984194)Hewlett-Packard Co.1999-04-30
DAUM NEUROGATE TROCAR (K990782)Daum GmbH1999-04-28
WATER TREATMENT SYSTEM FOR HEMODIALYSIS (K983512)Water Vault, Inc.1999-04-28
PBN DRAINAGE CATHETER GUIDEWIRES (K991097)Medical Device Technologies, Inc.1999-04-23
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS (K982413)Gambro Healthcare1999-04-21
URETERAL ACCESS SHEATH SET (K990775)Applied Medical Resources1999-04-21
SERIM BLOOD LEAK TEST STRIP (K990206)Serim Research Corp.1999-04-21
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (K990159)Dynamic Technology Corp.1999-04-19
ALTHIN MEDICAL AB ALTRACART II (K990010)Althin Medical AB1999-04-15
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB (K974236)Medical Components, Inc.1999-04-15
SMITH & NEPHEW HANDPORT SYSTEM (K990414)Smith & Nephew, Inc.1999-04-14
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 (K982134)Dynamic Technology Corp.1999-04-14
WILTEK HOT BIOPSY FORCEPS (K990231)Wiltek Medical, Inc.1999-04-13
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE (K990863)Ross Product Div. Abbott Laboratories1999-04-06
STERICHEK TOTAL CHLORINE TEST KIT (K983997)Environmental Test Systems, Inc.1999-04-02
POINT SETTER (K984355)Mitaka USA, Inc.1999-04-01
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE (K990028)Ethicon Endo-Surgery, Inc.1999-04-01
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 (K990188)Intuitive Surgical, Inc.1999-04-01
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM (K990220)Medi-Globe Corp.1999-03-31
COOPERSURGICAL INFRARED COAGULATOR FOR ENT (K990855)CooperSurgical, Inc.1999-03-30
DAUM NEUROCUT NEUROBIOPSYNEEDLE (K990278)Daum Corp.1999-03-30
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS (K982414)Gambro Healthcare1999-03-26
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