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Gastroenterology, Urology

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

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RecordFirmDate
RAPPORT V.T.D. (K971443)Owen Mumford USA, Inc.1997-09-26
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (K955497)Cobe Renal Care, Inc.1997-09-25
ANORECTAL MANOMETRY ANALYSIS MODULE (K972439)Medtronic-Synectics1997-09-23
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE (K971150)Mist, Inc.1997-09-23
GR100F URINE FLOWMETER (K971913)Albyn Medical , Ltd.1997-09-19
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) (K972679)Ethicon Endo-Surgery, Inc.1997-09-19
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS (K972958)Lysonix, Inc.1997-09-19
OT-1 (K972781)Prism Therapeutics, LLC1997-09-19
SILICONE BILIARY STENT/BILIARY CATHETER (K973114)Specialty Surgical Products, Inc.1997-09-19
RESUABLE HOT BIOPSY FORCEPS (K972505)United States Endoscopy Group, Inc.1997-09-18
S-357 VIDEO IMAGING SYSTEM (K972540)Sopro1997-09-18
AUXILIARY INSTRUMENTS FOR URS (K971315)Richard Wolf Medical Instruments Corp.1997-09-15
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) (K973259)Medical Creative Technologies, Inc.1997-09-10
JIMMY JOHN III RECTAL NOZZEL, MODEL CIT (K972455)Colon Therapeutics1997-09-09
BLOOD MONITOR PUMP (K970591)Baxter Healthcare Corp1997-09-09
5 STAR MEDICAL ENDOSCOPE (K963354)Five Star Medical, Inc.1997-09-08
UNISURGE INTERFACE P (K972178)Unisurge Holding, Inc.1997-09-05
FLEX-NECK PD CATHETER (K970159)Janin Group, Inc.1997-09-05
AMS FOREIGN BODY EXTRATOR (K972091)American Medical Systems, Inc.1997-08-29
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S (K972583)Uresil Corp.1997-08-29
FEMALE EXTERNAL URINARY COLLECTION POUCH (K971499)Mediquest, Inc.1997-08-28
SHIELDED SURGICAL TROCAR (K971475)Ethicon Endo-Surgery, Inc.1997-08-21
JEJENOSTOMY FEEDING TUBE (K971906)Boston Scientific Corp1997-08-20
NIAGARA DUAL LUMEN CATHETER (K965178)Vas-Cath, Inc.1997-08-19
MEDISYSTEMS DIALYSIS PRIMING SETS (K971860)Medisystems Corp.1997-08-18
POTTY PAL AND FOREVER-DRY (K971855)Digital Applications, Inc.1997-08-18
BESECURE EXTERNAL URINARY COLLECTION SYSTEM (K971271)Urology Research Intl., Inc.1997-08-18
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE (K971937)Terumo Medical Corp.1997-08-15
MEDISYSTEMS PERITONEAL DIALYSIS SETS (K963668)Medisystems Corp.1997-08-15
ENTERAL NUTRITION 1000 ML/500ML (K970849)Medical Infusion Technologies, Inc.1997-08-15
WILSON-COOK NEEDLE KNIFE PAPILLOTOME (K972674)Wilson-Cook Medical, Inc.1997-08-15
ELPHA 2000 CONTI (K964738)Dan Med, Inc.1997-08-14
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE (K972054)Empi1997-08-14
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS (K971796)Louisville Laboratories, Inc.1997-08-12
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE (K971977)KARL STORZ Endoscopy-America, Inc.1997-08-12
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS (K971881)Comeg Endoscopy1997-08-12
KARL STORZ MODEL 203020 20 EQUIMAT (K971982)KARL STORZ Endoscopy-America, Inc.1997-08-12
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES (K971850)Smith & Nephew, Inc.1997-08-12
MVM 3.3 MM MICROENDOSCOPE (K972504)KARL STORZ Endoscopy-America, Inc.1997-08-11
ZIP CONDOM CATHETER (K964219)Goulter Medical, Inc.1997-08-11
JMS AV FISTULA NEEDLE (K970962)Jms Co., Ltd.1997-08-07
ENDOPATH RESPOSABLE TROCAR SYSTEM (K971738)Ethicon Endo-Surgery, Inc.1997-08-07
SMITH & NEPHEW SUTURE COLLET (K971939)Smith & Nephew Endoscopy, Inc.1997-08-06
AMSINO URINARY LEG BAG (K971929)Amsino Intl., Inc.1997-08-06
FLEXILOG LS (K964804)Oakfield Instruments, Ltd.1997-08-06
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (K971992)Uromed Corp.1997-08-01
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR (K965001)Intuitive Surgical, Inc.1997-07-31
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (K972100)Advanced Care Medical Products1997-07-31
STANDARD ENDOSCOPE (K972056)Laser-Optik-Systeme GmbH & Co. KG1997-07-30
WELCON HUE-VU URINARY DRAINAGE BAG (K971764)Welcon, Inc.1997-07-29
GALLINI COAXIAL INTRODUCER (K972266)Gallini U.S., LLC1997-07-29
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME (K971687)National Medical Care, Inc.1997-07-29
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT (K971571)Waters Instruments, Inc.1997-07-29
VG 200 VIDEO GASTROSCOPE (K971734)Welch Allyn, Inc.1997-07-29
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT (K971660)Olympus America, Inc.1997-07-25
CYBERREN (K970989)Cybernius Medical , Ltd.1997-07-24
AMS COAGULOOP RESECTION ELECTRODE (K971512)American Medical Systems, Inc.1997-07-24
PATTISON ESOPHAGEAL DILATOR (K971615)Tri-Med Specialties, Inc.1997-07-24
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT (K971180)C.R. Bard, Inc.1997-07-24
LAPAROTOMY BLADDER NECK SUSPENSION KIT (K971801)Louisville Laboratories, Inc.1997-07-22
CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM (K970178)Corpak, Inc.1997-07-21
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II (K961392)Sil-Med Corp.1997-07-18
STERICHEK CHLORINE REAGENT STRIPS (K971598)Environmental Test Systems, Inc.1997-07-18
OLYMPUS OES OTV-S5C VIDEO SYSTEM (K971416)Olympus America, Inc.1997-07-16
MRI NEEDLES (K963565)Cook, Inc.1997-07-14
RPI DUAL PORT IRRIGATION ADAPTER (K964920)Ridge Products, Inc.1997-07-09
RMI HEMOCONCENTRATOR PREFERENCE PACK (K970739)Research Medical, Inc.1997-07-08
2008H ON LINE CLEARANCE MONITOR (K961465)Fresenius USA, Inc.1997-07-03
OLYMPUS CD-6C-1 COAGULATION ELECTRODE (K971328)Olympus America, Inc.1997-07-01
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM (K971527)Empi1997-06-30
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS (K965147)Boston Scientific Corp1997-06-30
ENDOSCOPE (K964131)Akos Biomedical, Inc.1997-06-27
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K963160)Olympus America, Inc.1997-06-27
STONE EXTRACTOR (K971123)Phx Technologies Corp.1997-06-27
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER (K970720)Ethicon Endo-Surgery, Inc.1997-06-27
I-SCOPE OPHTHALMIC ENDOSCOPE (K971679)Ophthalmic Technologies, Inc.1997-06-25
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON (K971541)Hollister, Inc.1997-06-25
CONTIDRAIN CATHETER (K964757)Contimed, Inc.1997-06-25
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) (K970882)American Medical Devices, Inc.1997-06-24
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT (K964688)Cordis Corp.1997-06-20
COAXIAL NEEDLE (K971842)United States Endoscopy Group, Inc.1997-06-20
DYNABITE HOT GI BIOPSY FORCEPS (K970083)Portlyn Corp.1997-06-17
ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS (K971053)International Medical Products, Inc.1997-06-16
HIGH RANGE PEROXIDE TEST STRIP (K964264)Integrated Biomedical Technology, Inc.1997-06-16
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT (K971230)Innerdyne, Inc.1997-06-13
ASPISAFE GASTRIC TUBE (K961711)B.Braun Medical, Inc.1997-06-11
PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR (K971334)Pilling Weck Group1997-06-11
SOLOS 10MM OPERATING LAPAROSCOPE (K970917)Woodbine Optical Corp.1997-06-10
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET (K970946)Medline Industries, Inc.1997-06-10
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (K964005)Synergetics, Inc.1997-06-09
ANOKRYO (K964634)Mk Conquest Intl., Inc.1997-06-06
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM (K963064)Laborie Medical Tech Corp.1997-06-05
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (K971911)Medamicus, Inc.1997-06-03
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM (K970446)Althin Medical AB an Affiliate of Baxter Intl1997-06-02
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP (K970526)Arthrocare Corp.1997-05-28
LSVP INTERNATIONAL HOT BIOPSY FORCEPS (K971204)Lsvp Intl., Inc.1997-05-27
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS (K971202)Comeg Endoskopie GmbH1997-05-27
#ES-32 SUCTION CATHETER 32 FR. (K970890)Tri-Med Specialties, Inc.1997-05-23
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (K971584)Clarus Medical Systems, Inc.1997-05-23
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (K970077)Utah Medical Products, Inc.1997-05-23
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