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Gastroenterology, Urology

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

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RecordFirmDate
ACHELASIA BALLOON DIALATOR (K884715)Primrose Medical, Inc.1989-09-29
FIBER OPTIC LIGHT TRANSMISSION CABLE (K892145)Opto Vision, Inc.1989-09-29
BILIARY DIALATOR (K884714)Primrose Medical, Inc.1989-09-29
DENVER PERITONEO-VENUS SHUNT (K894756)Codman & Shurtleff, Inc.1989-09-29
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE) (K891588)Ideal Medical, Inc.1989-09-28
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM (K892895)Everest Medical Corp.1989-09-25
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (K885220)Ethox Corp.1989-09-25
NATIONAL MEDICAL CARE VENOUS LINE 03-9548 (K894637)National Medical Care, Medical Products Div., Inc.1989-09-22
MODIFIED URINARY CATHETER INTRODUCER (UCI) (K890400)Go Medical Industries Pty. , Ltd.1989-09-12
BIPOLAR ELECTROSURGICAL SNARE (K893553)Everest Medical Corp.1989-09-08
GASTRO ENTEROLOGICAL BIOPTOME (K894419)Symbiosis Corp.1989-09-08
NOETIX, BIOPSY NEEDLE (K893992)Noetix, Inc.1989-09-08
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (K884709)Primrose Medical, Inc.1989-09-08
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH (K885168)Boston Scientific Corp1989-09-08
LAMANO DIRECTORS (K894592)Marlo Surgical Technology1989-09-08
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (K884712)Primrose Medical, Inc.1989-09-08
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP (K894783)Baxter Healthcare Corp1989-09-07
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB (K894838)Baxter Healthcare Corp1989-09-07
MODIFIED PRISTINE CULTURE CATHETER (K893390)Hml Medical, Inc.1989-09-07
HOBBS MEDICAL MICROBIOLOGY BRUSH (K893729)Hobbs Medical, Inc.1989-08-28
DIRECTABLE COAXIAL CATHETER SET (K894716)Cook Ob/Gyn1989-08-23
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI (K891773)Hollister, Inc.1989-08-23
UROPUMP* FLUID MANAGEMENT SYSTEM (K894363)Orthoconcept, Inc.1989-08-11
PEAK FLOW RATE METER (K893827)Laytech Medical Co.1989-08-11
EXTENDED COVERS, STERILE (K892069)Amedic USA1989-08-08
GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE (K892071)Amedic USA1989-08-08
TRT (ACUSON) NEEDLE GUIDE KIT, STERILE (K892068)Amedic USA1989-08-04
HYDRO-SAN COLONIC IRRIGATION SYSTEM (K891585)Specialty Health Products, Inc.1989-08-03
GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG (K891371)Entech, Inc.1989-08-03
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) (K890402)Mentor Corp.1989-08-03
PROSTATIC URETHRO. BALLOON DILATATION CATHETER (K873295)Medi-Tech, Inc.1989-07-31
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 (K893440)Welch Allyn, Inc.1989-07-28
TWO TANK DISSOLUTION MODULE (K893612)National Medical Care, Medical Products Div., Inc.1989-07-24
ENTERA-FLO SPIKE SET (K893209)Delmed, Inc.1989-07-24
PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET (K890093)Kells Medical, Inc.1989-07-24
SHUNT CONNECTORS (K893679)Akcess Medical Products, Inc.1989-07-24
PERITONEAL DIALYSIS SYSTEM AND ACCESS. (K893712)Delmed, Inc.1989-07-24
FILTRAL TM 20 HEMODIALYZER/FILTER (K893742)Hospal Medical Corp.1989-07-24
HOLLOW FIBER DIALYZER FOCUS 70H (K893677)National Medical Care, Medical Products Div., Inc.1989-07-24
BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (K890096)Medical Inventors Corp., Inc.1989-07-14
KENDALL CURITY IRRIGATION SYRINGE (K892436)The Kendal Co.1989-07-14
MARLOW ANAL SPECULUM (K891352)Simpson/Basye, Inc.1989-06-23
KENDALL CURITY URETHRAL CATHETERS (K892442)The Kendal Co.1989-06-23
KENDALL KENGUARD URINARY LEG BAGS (K892437)The Kendal Co.1989-06-23
CATHETERS, MALE, FEMALE (K892691)Zinnanti Surgical Instruments, Inc.1989-06-23
NASOGASTRIC PH SUCTION CATHETER, ST-5001 (K891410)Sensatronix Medical Systems, Inc.1989-06-23
KENDALL CURITY STOMACH TUBES (K892439)The Kendal Co.1989-06-23
NO. 86500 - ENDOSCOPIC JET WASHER (K892426)Superior Healthcare Group, Inc.1989-06-22
TERUMO AV FISTULA NEEDLE SET (K891062)Terumo Medical Corp.1989-06-22
BIOPRIME TM KIT (K892932)Hospal1989-06-22
CUFF SPECULUM (K893531)Mountain Medical Equipment, Inc.1989-06-22
VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM (K890047)Vascucare, Inc.1989-06-20
ENTERAL FEEDING CONTAINER (K890424)Multi-Med, Inc.1989-06-14
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C (K893439)Medical Components, Inc.1989-06-13
PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE (K890072)Medireach, Inc.1989-06-12
CLIRANS HOLLOW FIBER HEMODIALYZER (WET) (K891477)Terumo Medical Corp.1989-06-09
DELCLAMP (K893231)Delmed, Inc.1989-06-08
DA-16 AND DA-24 SHUNT ADAPTERS (K893478)Akcess Medical Products, Inc.1989-06-08
QUINTON SINGLE LUMEN CATHETER (K893188)Quinton, Inc.1989-06-08
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 (K891753)Akcess Medical Products, Inc.1989-06-08
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K (K891755)Akcess Medical Products, Inc.1989-06-08
T SERIES VESSEL TIPS (K893438)Akcess Medical Products, Inc.1989-06-08
IRRI-FLO IRRIGATION DELIVERY SYSTEM (K891339)Surgitek1989-06-02
ENTAINER(TM) ENTERAL FEEDING CONTAINER (K890430)Entech, Inc.1989-06-02
MDL-1 LASERTRIPTER(TM) (K885255)Candela Laser Corp.1989-06-01
LIB SYSTEM, BABY/ADULT DIAPER (K891686)Intera Corp.1989-05-31
ESOPHAGEAL OVERTUBE (K890629)Gastrotech, Inc.1989-05-31
ENDO-SPONGE (K892218)Endovations1989-05-31
LEONARD TUBE (K892334)Surgidyne, Inc.1989-05-31
URODEC 500 (K890284)Ferguson Medical1989-05-30
TECNOL NASO-GASTRIC TUBE HOLDER (K891187)Tecnol New Jersey Wound Care, Inc.1989-05-30
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 (K892648)Boston Scientific Corp1989-05-24
HEALTHSHIELD (K885345)Jonas, Inc.1989-05-24
TECNOL SECURE-ALL TUBE HOLDER (K891178)Tecnol New Jersey Wound Care, Inc.1989-05-23
ENTERAL BAG/SET (K890151)Ashley Health Care, Inc.1989-05-23
EXTERNAL FEEDING SET FOR PUMP USE (K890396)Multi-Med, Inc.1989-05-23
CLOSED SYSTEM URINARY DRAINAGE BAG (K890465)Cypress Medical Products, Ltd.1989-05-23
KENDALL CURITY FEEDING TUBES (K892431)The Kendal Co.1989-05-19
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD (K892872)National Medical Care, Medical Products Div., Inc.1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD (K892870)National Medical Care, Medical Products Div., Inc.1989-05-18
MODIFIED AM-SERIES DIALYZERS (K892375)Asahi Medical Co., Ltd.1989-05-18
PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD (K892871)National Medical Care, Medical Products Div., Inc.1989-05-18
NEW AM-SERIES DIALYZERS (K892374)Asahi Medical Co., Ltd.1989-05-18
ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA (K892887)Akcess Medical Products, Inc.1989-05-15
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (K890329)Fresenius USA, Inc.1989-05-11
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM (K890824)Fresenius USA, Inc.1989-05-11
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY (K892523)Gambro, Inc.1989-05-11
NICKLE-TITANIUM ORTHODONTIC WIRE (K891327)American Orthodontics1989-05-10
RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU (K892542)Zinnanti Surgical Instruments, Inc.1989-05-09
BEST COLON CLAMP (K892550)Zinnanti Surgical Instruments, Inc.1989-05-09
LIGHT SOURCE, ENDOSCOP, XENON ARC (K890448)Mira, Inc.1989-05-08
PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE (K891109)Concept, Inc.1989-05-08
KENDALL CURITY URINARY DRAINAGE BAGS (K892433)The Kendal Co.1989-05-05
PRO-CUT BIOPSY NEEDLE (K891777)Teknar, Inc.1989-05-04
S-100 ALLEN-BROWN SHUNT (K892663)Akcess Medical Products, Inc.1989-05-04
BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET (K892383)Porges Corp.1989-05-04
SAF-T-SHUNT, S-300 SERIES (K892666)Akcess Medical Products, Inc.1989-05-04
SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 (K892667)Akcess Medical Products, Inc.1989-05-04
BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER (K892384)Porges Corp.1989-05-04
BURNEY GALLBLADDER CATHETER KIT (K880343)Mallinckrodt Critical Care1989-05-01
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