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Gastroenterology, Urology

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

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RecordFirmDate
LAPAROSCOPIC KNITTER (K955490)Core Dynamics, Inc.1996-01-22
ENDOSCOPIC CATHETER (K953967)Act Medical, Inc.1996-01-22
FORMALIN REUSE CART (K941757)National Medical Care, Medical Products Div., Inc.1996-01-22
RENALIN REUSE CART (K941867)Renal Scientific Service, Inc.1996-01-22
LUMAX(MODIFICATION) (K953734)Medamicus, Inc.1996-01-18
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (K955051)Olympus America, Inc.1996-01-18
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (K953453)Symbiosis Corp.1996-01-17
DIALYSIS ADMINISTRATION KITS (K952572)B.Braun Medical, Inc.1996-01-11
GAMBRO HC 14R HEMOCONCENTRATOR (K951311)Cobe Renal Care, Inc.1996-01-11
INFANT FEEDING TUBE (K953008)Marquette Medical, Inc.1996-01-11
LUMAX (MODIFICATION) (K954093)Medamicus, Inc.1996-01-11
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR (K952581)Gamp & Assoc.1996-01-05
GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR (K952585)Gamp & Assoc.1996-01-05
AUTOMATED TRU-CUT BIOPSY DEVICE (K954529)Baxter Healthcare Corp1995-12-29
CONVEEN URINE BAG - STERILE (K955609)Coloplast Corp.1995-12-29
ENDO-LEADER (K954641)Microsurge, Inc.1995-12-28
WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP (K954649)Wilson Greatbatch Technologies, Inc.1995-12-22
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (K952343)National Medical Care, Medical Products Div., Inc.1995-12-22
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE (K954519)Mill-Rose Laboratory1995-12-22
AUTO SUTURE SUTURE CLOSURE (K954853)United States Surgical, A Division of Tyco Healthc1995-12-20
PROSYS BEDSIDE DRAINAGE BAG (K953767)Convatec, A Division of E.R. Squibb & Sons1995-12-20
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY (K943307)Olympus America, Inc.1995-12-20
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY (K943304)Olympus America, Inc.1995-12-20
MILL-ROSE ROTATABLE POLYPECTOMY SNARE (K951600)Mill-Rose Laboratory1995-12-18
SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER (K950042)Accurate Surgical Instruments Co.1995-12-15
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS (K954349)Minntech Corp.1995-12-15
AWESMOSIS (K945066)Applied Water Engineering, Inc.1995-12-15
OLYMPUS FG-45/46-1 GRASPING FORCEPS (K955049)Olympus America, Inc.1995-12-15
URINARY GEL DRAINAGE SYSTEM (K952780)P.A.M., Inc.1995-12-12
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES (K946249)C.R. Bard, Inc.1995-12-11
KOH MICRO-SUTURING INSTRUMENTS (K955479)KARL STORZ Endoscopy-America, Inc.1995-12-08
CAP-AID (K954959)Nebl, Inc.1995-12-06
UROTRACT I (K955019)Dornier Medtech America, Inc.1995-12-06
MSV-2000 VIDEO IMAGING SYSTEM (K954160)Applitec, Ltd.1995-12-04
CYSTOSCOPE (K941992)Surgical Technologies, Inc.1995-11-30
PVC ABDOMINAL/RECTAL PRESSURE CATHETER (K954315)Life-Tech Intl., Inc.1995-11-30
PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS (K950602)Reprocessing Products Corp1995-11-30
BLADE, SCALPEL & BLADE, HANDEL (K954536)Access Surgical Intl., Inc.1995-11-29
BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (K930181)Fresenius USA, Inc.1995-11-29
DRS 4 ND DIALYZER REPROCESSING SYSTEM (K944539)Seratronics, Inc.1995-11-29
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (K944767)Fresenius USA, Inc.1995-11-29
MILL-ROSE RIGID SCOPE CLEANING BRUSHES (K954745)Mill-Rose Laboratory1995-11-27
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) (K953876)Pentax Precision Instrument Corp.1995-11-24
XCHF-33 CHOLEDOCHOFIBERSCOPE (K944473)Olympus America, Inc.1995-11-22
RESECTOSCOPES (K954050)KARL STORZ Endoscopy-America, Inc.1995-11-22
CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS (K946109)Cabot Medical Corp.1995-11-21
LOW PROFILE CATHETER (K922567)Rusch, Inc.1995-11-21
DANTEC DA CAPO (K953999)Dantec Medical, Inc.1995-11-21
TS 564/PF (K950247)Bressler, Amery & Ross1995-11-17
GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES (K951421)Global Medical Products, Ltd.1995-11-16
THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR (K952902)The Tulip Mfg. Co.1995-11-14
THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR (K952951)The Tulip Mfg. Co.1995-11-14
THE TULIP COMPANY BRANSON #1 ELEVATOR (K952932)The Tulip Mfg. Co.1995-11-14
THE TULIP CXOMPANY BRANSON #2 ELEVATOR (K952953)The Tulip Mfg. Co.1995-11-14
THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR (K952901)The Tulip Mfg. Co.1995-11-14
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) (K954734)The Tulip Mfg. Co.1995-11-14
THE TULIP COMPANY BRANSON OVERSHEATH (K952958)The Tulip Mfg. Co.1995-11-14
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] (K954174)Origin Medsystems, Inc.1995-11-09
DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES] (K954175)Origin Medsystems, Inc.1995-11-09
SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (K954116)Technical Products, Inc.1995-11-06
SURGICAL INTEGRATED CAMERA SYSTEM (K953438)Envision Medical Corp.1995-11-06
FCP-9P, FIBER CHOLEDOCHOSCOPE (K953286)Pentax Precision Instrument Corp.1995-11-03
STERILE FEEDING TUBE (K954218)Baxter Healthcare Corp1995-11-03
ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE (K954089)Ethicon Endo-Surgery, Inc.1995-11-02
MITEK MINI ANCHOR (K936311)Mitek Surgical Products, Inc.1995-10-31
THE TULIP COMPANY BRANSON STRAIGHT DISSECTOR (K952955)The Tulip Mfg. Co.1995-10-30
PEDIATRIC EUROPHYLIC FOLEY CATHETER (K954752)Regulatory & Marketing Services, Inc.1995-10-30
THE TULIP INSULATED SCISSORS (K952899)The Tulip Mfg. Co.1995-10-30
NEEDLE OR CUTTER (K953399)Biophysic Medical, Inc.1995-10-30
THE TULIP COMPANY BRANSON ANTERIOR ELEVATOR (K952936)The Tulip Mfg. Co.1995-10-30
THE TULIP COMPANY BRANSON SOFT TISSUE RETRACTOR (K952900)The Tulip Mfg. Co.1995-10-30
THE TULIP COMPANY BRANSON RECURVED DISSECTOR (K952934)The Tulip Mfg. Co.1995-10-30
THE TULIP INSULATED GRASPERS (K952957)The Tulip Mfg. Co.1995-10-30
THE TULIP COMPANY WEIL-BLAKESLEY FORCEPS (K952954)The Tulip Mfg. Co.1995-10-30
THE TULIP COMPANY BRANSON DOUBLE-ENDED DISSECTOR (K952956)The Tulip Mfg. Co.1995-10-30
DUNA II PENILE PROSTHESIS (K953640)Dacomed Corp.1995-10-27
MICROSURGE PUNCTURE CLOSE DEVICE (K954072)Microsurge, Inc.1995-10-26
FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC (K954377)Annex Medical, Inc.1995-10-26
MITEK ABSORBABLE ANCHOR (K941599)Mitek Surgical Products, Inc.1995-10-24
KSEA REVERSE VIDEO (K952482)KARL STORZ Endoscopy-America, Inc.1995-10-23
MEHTA BRONCHIAL BIOSPY DRILL (K954693)United States Endoscopy Group, Inc.1995-10-23
DISTENTION BALLOON (K953377)Origin Medsystems, Inc.1995-10-23
LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM (K953903)Core Dynamics, Inc.1995-10-20
INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM (K951627)Infinitech, Inc.1995-10-19
XENON NOPPVA (K954561)KARL STORZ Endoscopy-America, Inc.1995-10-19
MODIFIED VERSAPORT (K954108)United States Surgical, A Division of Tyco Healthc1995-10-17
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC (K930530)Hollister, Inc.1995-10-17
URODYNAMICS TUBING AND INFUSION SETS (K954341)Life-Tech Intl., Inc.1995-10-17
LAPAROSCOPIC TROCAR (K953409)Core Dynamics, Inc.1995-10-16
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (K953691)Meadox Medicals, Div. Boston Scientific Corp.1995-10-16
J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS (K953655)Johnson & Johnson Medical, Inc.1995-10-13
GASTROINTESTINAL TUBES & ACCESSORIES (K945618)Applied Medical Technologies1995-10-12
LOWER BOWEL EVACUATION SYSTEM (K941279)Tiller Mind Body, Inc.1995-10-12
CYTOLOGY BRUSH (K954121)Lighthouse Medical, Inc.1995-10-07
ELECTROCAUTERY SHROUD (K953418)I.C Medical, Inc.1995-10-07
PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM (K954596)Promedical , Ltd.1995-10-07
MS CLASSIQUE BALLOON DILATATION CAHTETER (K953332)Meadox Medicals, Div. Boston Scientific Corp.1995-10-07
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER (K953597)Meadox Medicals, Div. Boston Scientific Corp.1995-10-07
BRAUN DIACAN(R) FISTULA NEEDLES (K945850)B. Braun of America, Inc.1995-10-06
ALTRA FLUX 110 HEMODIALYZER (K952978)Althin Medical AB an Affiliate of Baxter Intl1995-10-05
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