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Gastroenterology, Urology

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

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RecordFirmDate
SABRE MULTI-USE TROCAR SYSTEM (K952977)Endoscopic Concepts, Inc.1995-07-17
DEVMED REUSEABLE TROCAR SYSTEM (K952723)Devmed Group, Inc.1995-07-11
INTRODUCER (K951090)Ranfac, Corp.1995-07-11
ETHICON ARTHROSCOPIC KNOT PUSHER (K952814)ETHICON, Inc.1995-07-11
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (K951721)Applied Medical Resources1995-07-11
CLEAR ADVANTAGE II (K945628)Mentor Corp.1995-07-06
PIPER, MODEL NUMBER UDS-PIPERB (K951805)Laborie Medical Technologies, Ltd.1995-07-06
AMS 650 MALLERABLE PENIEL PROSTHESIS (K951716)American Medical Systems, Inc.1995-07-06
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (K951533)Ballard Medical Products1995-07-05
GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES (K941973)Medi-Globe Corp.1995-06-30
COMBINATION CAMERA/LIGHT SOURCE (K951386)M.P. Video, Inc.1995-06-30
FS-34P2, FIBER SIGMOIDOSCOPE (K951576)Pentax Precision Instrument Corp.1995-06-29
SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA (K951878)General Surgical Innovations1995-06-29
EUROPHILIC SLIPPERY COATED FOLEY CATHETER (K944007)Baxter Healthcare Corp1995-06-29
FC-38TLH, FIBER COLONOSCOPE (K951575)Pentax Precision Instrument Corp.1995-06-27
FC-38LH, FIBER COLONOSCCOPE (K951580)Pentax Precision Instrument Corp.1995-06-27
FS-38H, FIBER SIGMOIDOSCOPE (K951573)Pentax Precision Instrument Corp.1995-06-27
FS-38X, FIBER SIGMOIDOSCOPE (K951572)Pentax Precision Instrument Corp.1995-06-27
FC-38LX, FIBER COLONOSCOPE (K951578)Pentax Precision Instrument Corp.1995-06-27
EW-10 AND EW-20 (K915402)Olympus Corp.1995-06-23
PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER (K952414)Acacia Laboratories, Inc.1995-06-23
FILTRYZER (K942681)Toray Industries (America), Inc.1995-06-22
ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS (K951546)Ethicon Endo-Surgery, Inc.1995-06-21
LAPAROSCOPIC SURGERY INSTRUMENTS (K932033)Medline1995-06-19
WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA (K951522)Woodbine Optical Corp.1995-06-16
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE (K951479)Trinity Laboratories, Inc.1995-06-15
STANDARD FOLEY SYSTEM PAK (K951443)Trinity Laboratories, Inc.1995-06-15
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS (K952149)KARL STORZ Endoscopy-America, Inc.1995-06-15
ACCESS EXPANSION SYSTEM (K951894)Micro-Medical Devices, Inc.1995-06-15
RUSCH URODYNAMIC RECTAL BALLOON CATHETER (K952573)Rusch Intl.1995-06-15
RUSCH INTERNATIONAL URODYNAMIC CATHETERS (K952029)Rusch Intl.1995-06-13
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K920186)Better Water, Inc.1995-06-13
OLYMPUS NBD TUBES (K944912)Olympus America, Inc.1995-06-13
FLEXILOG 2000 (K945069)Oakfield Instruments, Ltd.1995-06-13
ASLAN LAPRETRACT (K952264)Aslan Medical Technologies, Ltd.1995-06-12
INSULATED ELECTROSURGICAL INSTRUMENTS (K951986)KARL STORZ Endoscopy-America, Inc.1995-06-09
CORPAK GASTROSTOMY TUBE (K931921)Corpak Co.1995-06-09
NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS (K952421)American Hydro-Surgical Instruments, Inc.1995-06-08
GRASSI GASTROJEJUNOSTOMY TUBE (K932880)Bissell Medical Products, Inc.1995-06-07
MRI'S ALL SILICONE GASTROSTOMY TUBE (K951489)Manufacturing & Research, Inc.1995-06-07
SURGACTIVATOR (K951569)Deschutes Medical Products, Inc.1995-06-06
DYNABITE UROLOGICAL FORCEPS (K952391)Portlyn Corp.1995-06-01
NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS (K951733)American Hydro-Surgical Instruments, Inc.1995-05-31
CONTINUOUS FLOW BIOPSY PROBE (K942626)Gm Engineering, Inc.1995-05-30
FE-24X, FIBER ESOPHAGOSCOPE (K951197)Pentax Precision Instrument Corp.1995-05-30
ALTRA NOVA(TM) 140 HEMODIALYZER (K945625)Althin Medical AB an Affiliate of Baxter Intl1995-05-30
FE-34TH, FIBER ESOPHAGOSCOPE (K951198)Pentax Precision Instrument Corp.1995-05-30
ALTRA NOVA(TM) 170 HEMODIALYZER (K945621)Althin Medical AB an Affiliate of Baxter Intl1995-05-30
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE (K951191)Pentax Precision Instrument Corp.1995-05-30
URETHRAL CATHETERIZATION TRAY (K950390)Medcare Custom Packaging, Inc.1995-05-30
GIP/MEDI-GLOBE POLYPECTOMY SNARES (K943935)Medi-Globe Corp.1995-05-26
GIP/MEDI-GLOBE PAPILLOTOME (K943629)Medi-Globe Corp.1995-05-26
OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES (K945262)Optus, Inc.1995-05-26
LAPAROSCOPIC CLAMP (K950702)Applied Medical Resources1995-05-25
MCA(TM) 180 HEMODIALYZER (K945622)Althin Medical AB an Affiliate of Baxter Intl1995-05-25
SILICONE FOLEY CATHETER (K951106)Cook Urological, Inc.1995-05-25
PROSYS LEG BAG (K951945)Convatec, A Division of E.R. Squibb & Sons1995-05-25
KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES (K950862)Karl Storz Imaging, Inc.1995-05-24
XENON LIGHT SOURCE (K951971)Envision Medical Corp.1995-05-24
PRO'TECT (K943558)Health Sense Intl., Inc.1995-05-24
REMOTE A'LERT (K943559)Health Sense Intl., Inc.1995-05-24
KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR (K951995)Karl Storz Endoskop GmbH1995-05-24
ACCU-BEAM 300W XENON LIGHT SOURCE (K951895)Tti Medical1995-05-24
ALTRA FLUX(TM) 170 HEMODIALYZER (K945542)Althin Medical AB an Affiliate of Baxter Intl1995-05-23
FNA BIOPSY NEEDLE (K941722)Betta Medical, Inc.1995-05-22
FILTRYZER(TM) (K935471)Toray Industries (America), Inc.1995-05-19
155 SCE(TM) HEMODIALYZER (K945631)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
MCA(TM) 130 HEMODIALYZER (K945623)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
ALTRA FLUX(TM) 140 HEMODIALYZER (K945620)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
MCA(TM) 160 HEMODIALYZER (K945624)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
WELCH ALLYN HI - LUX ILLUMINATOR (K951647)Welch Allyn, Inc.1995-05-17
STONE DISLODGER, BASKET (K951309)Boston Scientific Corp1995-05-17
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT (K951625)KARL STORZ Endoscopy-America, Inc.1995-05-16
CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO (K950753)Stephen Chakoff, Inc.1995-05-15
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (K924306)United States Endoscopy Group, Inc.1995-05-15
ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (K926073)Surgimark, Inc.1995-05-15
COBE CENTRYSYSTEM CS500 DIALYZER (K941708)C.G.H. Medical, Inc.1995-05-12
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES (K945907)KARL STORZ Endoscopy-America, Inc.1995-05-12
PROSYS URIHESIVE SYSTEM LA (K951530)Convatec, A Division of E.R. Squibb & Sons1995-05-12
ENDO IRRIGATOR 2211, INCLUDING TUBING (K951715)Richard Wolf Medical Instruments Corp.1995-05-12
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP: (K950658)Innerdyne, Inc.1995-05-12
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP (K950632)Innerdyne, Inc.1995-05-12
MIST ENDOSCOPIC NEEDLES (K951648)Mist, Inc.1995-05-12
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS (K950975)Karl Storz Imaging, Inc.1995-05-11
FST FIBEROPTIC PRESSURE CONVERTER (K945753)Fiberoptic Sensor Technlogies, Inc.1995-05-11
METEL URETERAL BASKET STONE DISLODGER (K951761)Annex Medical, Inc.1995-05-11
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS (K950974)Karl Storz Imaging, Inc.1995-05-11
KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS (K951535)KARL STORZ Endoscopy-America, Inc.1995-05-09
IMPLANTABLE STAPLE (K950562)United States Surgical, A Division of Tyco Healthc1995-05-09
TROCAR SUPRAPUBIC, NON-DISPOSABLE TROCAR, DISPOSABLE (K950959)Miller Instrument, Inc.1995-05-09
CCD ENDOCAM 5501 (K950502)Richard Wolf Medical Instruments Corp.1995-05-04
FILTRYZER (K940910)Toray Industries (America), Inc.1995-05-04
ENDOSCOPIC ACCESSORY (K945191)Un-I-Med, Inc.1995-05-03
BAXTER BIOSTAT 1000 UREA MONITOR (K925581)Baxter Healthcare Corp1995-05-03
MIST ENDOSCOPIC CANNULAS (K951481)Mist, Inc.1995-05-03
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (K950784)Advanced Bioresearch Assoc.1995-05-03
OLYMPUS FD-5 HOT BIOPSY FORCEPS (K951445)Olympus America, Inc.1995-05-03
MIST REDUCER SLEEVES (K951398)Minimally Invasive Surgical Technologies, Inc.1995-05-03
MIST TROCARS (K951480)Mist, Inc.1995-05-03
MIST ENDOSCOPIC PROBES (K951692)Mist, Inc.1995-05-03
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