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Gastroenterology, Urology

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

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RecordFirmDate
S-52 ELECTRONIC VIDEO LAPAROSCOPE (K962651)Del Medical Systems Corp.1996-09-30
ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR (K960301)Del Medical Systems Corp.1996-09-30
ARTERIAL VENOUS BLOOD TUBING SET (K953823)Medisystems Corp.1996-09-23
ENDOBEAM (K963044)Corin USA1996-09-20
ENDOSPOT (K963043)Corin USA1996-09-20
COBE CENTRYSYSTEM 700 HG HEMODIALYZER (K962427)Gambro Healthcare1996-09-20
FLEXSCOPE (K961536)Matrix Medica, Inc.1996-09-18
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE (K961345)Applied Medical Technologies1996-09-17
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (K962393)KARL STORZ Endoscopy-America, Inc.1996-09-17
BRAUN HEMODIALYSIS CATHETER (K952660)B.Braun Medical, Inc.1996-09-17
OLYMPUS MH-246R BALLOON SHEATH (K961048)Olympus America, Inc.1996-09-16
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] (K962506)Gynecare Innovation Center1996-09-16
DANTEC DUET (K960503)Dantec Medical, Inc.1996-09-16
SELF RETAINING MALE EXTERNAL URINARY CATHETER (K962900)Hollister, Inc.1996-09-16
EG-3800T, VIDEO GASTROSCOPE (K962460)Pentax Precision Instrument Corp.1996-09-16
MAHURKAR 8 FR DUAL LEMEN CATHETER (K955002)Quinton, Inc.1996-09-13
BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL (K961039)Dayspring Medical, Inc.1996-09-12
HEAD MOUNTED DISPLAY (K961800)Vista Medical Technologies, Inc.1996-09-11
AIRLIFT BALLOON RETRACTON SYSTEM (K962104)Origin Medsystems, Inc.1996-09-11
ENDOSCOPIC CLIP APPLIER (K962493)Aesculap, Inc.1996-09-11
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS (K962595)KARL STORZ Endoscopy-America, Inc.1996-09-04
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT (K962375)Boston Scientific Corp1996-09-04
S-41 & S-41S VIDEO IMAGING SYSTEM (K962020)Del Medical Systems Corp.1996-08-30
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE (K961697)Medical Device Intl., Inc.1996-08-30
KSEA VAPORIZATION ELECTRODES (K961702)Karl Storz Endoskop GmbH1996-08-29
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) (K962259)Tiller Mind Body, Inc.1996-08-29
CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE (K935512)Corpak Co.1996-08-29
PORTLAND TROCARS (K962193)Surgical Innovations Plc1996-08-28
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) (K954623)Gambro Healthcare1996-08-28
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (K962472)Rusch Intl.1996-08-27
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY (K960903)KARL STORZ Endoscopy-America, Inc.1996-08-22
DIALYSIS MIXING & HOLDING TANK (K961416)Dial Medical Supply1996-08-21
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS (K960474)Cobe Renal Care, Inc.1996-08-14
NHMC IRRIGATION TRAY (K962670)National Healthcare Mfg. Corp.1996-08-14
EXTRAHAND BALLOON RETRACTOR (K962005)Origin Medsystems, Inc.1996-08-12
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER (K961872)Hollister, Inc.1996-08-09
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM (K954987)Althin Medical AB an Affiliate of Baxter Intl1996-08-08
PAPILLOTOME (K962346)United States Endoscopy Group, Inc.1996-08-08
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 (K961825)Baxter Healthcare Corp1996-08-06
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM (K960574)Sherwood Medical Co.1996-08-05
CATH CADDIE (K961884)Mark-Clark1996-08-01
UROSURGE ACUTRAINER (K962770)Princeton Regulatory Assoc.1996-08-01
SNARE (K960230)Lighthouse Medical, Inc.1996-07-31
BALLON DILATATION CATHETER (K961438)Boston Scientific Corp1996-07-31
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (K962387)Olympus America, Inc.1996-07-31
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955762)Fresenius USA, Inc.1996-07-31
SPHINCTEROTOME (K960231)Lighthouse Medical, Inc.1996-07-31
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER (K962077)C.R. Bard, Inc.1996-07-30
DALE GASTROSTOMY TUBE HOLDER (K961693)Dale Medical Products, Inc.1996-07-30
NHMC URETHRAL CATHETERIZATION TRAY (K962254)National Healthcare Mfg. Corp.1996-07-29
DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) (K954713)Ideas For Medicine, Inc.1996-07-24
DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER (K960176)C.R. Bard, Inc.1996-07-24
SUBCUTANEOUS URINARY DIVERSON STENT SET (K961371)Cook Urological, Inc.1996-07-24
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) (K953875)In-Line Diagnostics Corp.1996-07-23
REUSABLE ENDOSCOPIC ACCESSORY HANDLE (K961762)United States Endoscopy Group, Inc.1996-07-22
DRYTIME FOR BLADDER CONTROL SILENT (K962416)Bio-Systems Research1996-07-22
3D SCOPE (K961182)Oktas1996-07-19
OLYMPUS BASKET GRASPERS (UROLOGY) (K961611)Olympus America, Inc.1996-07-18
XENON LIGHTSOURCE (K962365)Dsp Worldwide1996-07-18
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING (K962604)Convatec, A Division of E.R. Squibb & Sons1996-07-18
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (K962384)Sierra Laboratories, Inc.1996-07-15
NEEDLE CATHETER (K961846)Boston Scientific Corp1996-07-15
MBI FIBEROPTIC ENDO-ILLUMINATOR (K961036)M.B. Industries, Inc.1996-07-15
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (K962413)Sierra Laboratories, Inc.1996-07-15
INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP (K961940)Innerdyne, Inc.1996-07-10
ED-344OT (K961568)Pentax Precision Instrument Corp.1996-07-09
S-57 VIDEO IMAGING SYSTEM (K962024)Del Medical Systems Corp.1996-07-09
DEXTERITY PNEUMO SLEEVE SET (K962147)Medical Creative Technologies, Inc.1996-07-09
EG-2940, VIDEO GASTROSCOPE (K961564)Pentax Precision Instrument Corp.1996-07-09
LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS (K955845)Surgical Image Laboratories, Inc.1996-07-05
SPECIMEN RETRIEVAL BAG (K962395)Applied Medical Resources1996-07-05
FRESENIUS BLOOD TEMPERATURE MONITOR (K941460)Fresenius USA, Inc.1996-07-03
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (K960173)Gabriel Medical, Inc.1996-06-27
LIBERTY LITE PFS SYSTEM (K960496)Utah Medical Products, Inc.1996-06-27
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 (K942867)Clearwater Colon Hydrotherapy, Inc.1996-06-26
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER (K961390)Ethicon Endo-Surgery, Inc.1996-06-25
ES-3840, VIDEO SIGMOIDOSCOPE (K961567)Pentax Precision Instrument Corp.1996-06-24
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) (K961570)Pentax Precision Instrument Corp.1996-06-24
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY (K962073)Continental Medical Laboratories, Inc.1996-06-21
KNOW-RECIRC (K953551)H&H Control Systems1996-06-21
EC-384OTL, VIDEO COLONSCOPE (K961563)Pentax Precision Instrument Corp.1996-06-19
ATI PLASMA PUMP (PP-04) (K961137)Apheresis Technologies, Inc.1996-06-14
5MM ENDOSCOPE (K960637)Origin Medsystems, Inc.1996-06-14
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955423)Fresenius USA, Inc.1996-06-13
BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC (K961040)Dayspring Medical, Inc.1996-06-11
AQ HYDROPHILIC UROLOGICAL CATHETERS (K962004)Cook Urological, Inc.1996-06-11
ESOPHAGEAL MANOMETRY ANALYSIS MODULE (K961070)Synectics Medical, Inc.1996-06-11
LESE STENTS SETS (K952513)Cook Urological, Inc.1996-06-10
BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL (K961026)Dayspring Medical, Inc.1996-06-10
BIOVIEW MODEL S960000 (K961056)Sandhill Scientific, Inc.1996-06-06
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE (K955181)United States Endoscopy Group, Inc.1996-06-05
NIPRO ARTERIAL VENOUS FISTULA NEEDLE (K955182)Nissho Corp.1996-06-04
7100 SWALLOWING WORKSTATION (K954798)Kay Elemetrics Corp.1996-06-04
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS (K945559)Mar Cor Services, Inc.1996-05-28
INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP (K961430)Innerdyne, Inc.1996-05-28
AQ HYDROPHILIC STENT (K961446)Cook Urological, Inc.1996-05-28
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM (K961069)Arthrocare Corp.1996-05-28
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS (K961248)C.R. Bard, Inc.1996-05-28
MANAN INTRODUCER SHEALTH/NEEDLE (K961216)Manan Medical Products, Inc.1996-05-23
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT (K955248)United States Endoscopy Group, Inc.1996-05-21
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