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Gastroenterology, Urology

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

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RecordFirmDate
PORGES STEPPED NEOPLEX DILATOR (K883526)Porges Corp.1988-10-28
ADD-A-CATH (K884061)Femcare , Ltd.1988-10-25
REDY 2000 (K882428)Organon Teknika Corp.1988-10-25
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION (K883173)KARL STORZ Endoscopy-America, Inc.1988-10-25
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 (K883644)Baxter Healthcare Corp1988-10-21
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 (K883534)Baxter Healthcare Corp1988-10-21
INTROCULAR FLUID INJECTOR (K881707)B&B Medical Assoc., Inc.1988-10-21
BARD URETEROSCOPIC DEVICE (K883110)C.R. Bard, Inc.1988-10-21
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS (K883239)Baxter Healthcare Corp1988-10-21
MAXERECT (K881008)Kenneth Chapman1988-10-12
AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 (K882551)Intl. Biomedics, Inc.1988-10-12
LAKE FOLEY CATHETERIZATION TRAY (K883610)Lake Medical Products, Inc.1988-10-12
TONOMITOR (TM) + SUMP (K883234)Tonometrics, Inc.1988-10-12
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (K883307)Hospal Medical Corp.1988-10-12
DRY COMFORT UNDERGARMENT (K882418)Health Tec, Inc.1988-09-29
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER (K883589)Gambro, Inc.1988-09-29
MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND (K883023)Mentor Corp.1988-09-29
ACCUFLO UF CONTROL MODULE NO. 74-0100-3 (K883490)National Medical Care, Medical Products Div., Inc.1988-09-29
BARD BIOPSY NEEDLE GUIDANCE DEVICE (K883374)C.R. Bard, Inc.1988-09-29
ACS ANGIOSCOPE GUIDE WIRE (K883000)Advanced Cardiovascular Systems, Inc.1988-09-28
ACS CORONARY ANGIOSCOPIC CATHETER (K875108)Advanced Cardiovascular Systems, Inc.1988-09-27
CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (K882867)Corpak Co.1988-09-21
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS (K881811)Cobe Laboratories, Inc.1988-09-15
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS (K881478)Keymed (Medical & Industrial Equipment), Ltd.1988-09-14
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE (K870722)National Medical Care, Medical Products Div., Inc.1988-09-14
FILLING VOLUME OPTION (K882295)Eris Medical Technology1988-09-13
COMPAT (R) ENTERAL DELIVERY SYSTEM (K882218)Sandoz Nutrition1988-09-13
FRESENIUS F8 DIALYZER (K883195)Fresenius USA, Inc.1988-09-13
MRM GASTROSTOMY BELT (K882089)Mrm Products, Inc.1988-09-13
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL (K881469)Baxter Healthcare Corp1988-09-12
ANOTRON(R) INCONTINENCE CONTROL SYSTEM (K882555)Biosonics, Inc.1988-08-30
GAMBRO MULTIPURPOSE SYSTEM MPS-10 (K881270)Gambro, Inc.1988-08-24
GASTROSTOMY FEEDING TUBE (K883336)Gastrotech, Inc.1988-08-23
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE (K883351)Gastrotech, Inc.1988-08-23
MODIFIED TORAY FILTRYZER DIALYZERS (K882158)Toray Industries (America), Inc.1988-08-12
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH (K881667)The Kendal Co.1988-08-12
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP (K881678)Hollister, Inc.1988-08-11
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. (K880581)Synectics-Dantec1988-08-11
SURGITEK CO2 DELIVERY SYSTEM (K881736)Medical Engineering Corp.1988-08-11
MODEL 90DX MULTITEST METER (K882032)Mesa Medical, Inc.1988-08-11
MIC NEEDLE JEJUNOSTOMY TUBE KIT (K880767)Medical Innovations Corp.1988-08-11
FOLEY-TEMP(TM) (K882130)Mallinckroot, Inc.1988-08-09
BALL TIP FULGURATING ELECTRODE, 3 FRENCH (K880748)Cook Urological, Inc.1988-08-04
ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM (K881981)Ryder Intl. Corp.1988-08-02
CATHETER STRAP (K881781)Baxter Healthcare Corp1988-08-02
PANAMEX(TM) URETERAL STENT (K882157)Kingston Technologies, Inc.1988-08-02
COMFORT CATH MALE EXTERNAL CATHETER (K883057)Sierra Laboratories, Inc.1988-08-02
VPI NON-ADHESIVE CONDOM CATHETER (K883119)Cook Urological, Inc.1988-08-02
GENT-L-KARE STERILE URINARY LEG BAG (K881217)Geneva Laboratories, Inc.1988-07-29
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER (K881213)Geneva Laboratories, Inc.1988-07-28
SIGMA 1 WOBBLER BIOPSY KIT (K882673)Kontron Instruments, Inc.1988-07-28
GENT-L-KARE CLEANSING ENEMA SET (K881218)Geneva Laboratories, Inc.1988-07-28
CATHETER WITHDRAWAL UNIT (K881878)Eris Medical Technology1988-07-28
BATTERY PACKS (OTHER THAN CV) (K881885)Dowit Service Co., Inc.1988-07-26
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY (K880775)Medsurg Industries, Inc.1988-07-25
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA (K882680)Baxter Healthcare Corp1988-07-22
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. (K882549)Acuson Corp.1988-07-21
JIMMY JOHN III (K881720)Colon Therapeutics1988-07-20
MEDSURG ACUTE DIALYSIS TRAY (K880778)Medsurg Industries, Inc.1988-07-15
EXTENDED LIFE CAPD TRANSFER SET 5C4444 (K882498)Baxter Healthcare Corp1988-07-13
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (K881636)Coloplast A/S1988-07-13
ENTERAL FEEDING TUBES (K881978)Primrose Medical, Inc.1988-07-13
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373 (K882455)Baxter Healthcare Corp1988-07-13
VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER (K882466)Vas-Cath, Inc.1988-07-13
PROXIMA 1 PH MONITOR (K881706)Technomanagement, Inc. C/O C.G.1988-07-12
TECNOL CATHETER LEG STRAP (K882641)Tecnol New Jersey Wound Care, Inc.1988-07-12
SITZMARKS (K881609)Lafayette Pharmacal, Inc.1988-07-08
NEPHROSS I.Q. ALLEGO (K882213)Organon Teknika Corp.1988-06-28
NEPHROSS I.Q. MODERATO (K882215)Organon Teknika Corp.1988-06-28
BIO*NEPHROSS I.Q. ANDANTE (K882339)Organon Teknika Corp.1988-06-28
DESERET SUBCLAVIAN HEMODIALYSIS CATHETER (K881695)Deseret Medical, Inc.1988-06-23
VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER (K881743)Vas-Cath, Inc.1988-06-23
SYRINGE PREFILLED WITH WATER (K881363)I M, Inc.1988-06-23
DENVER PLEURO-PERITONEAL SHUNT (K880570)Codman & Shurtleff, Inc.1988-06-20
MODIFIED COPE SUTURE ANCHOR (K873606)Cook, Inc.1988-06-17
MCT MEDICAL BROWNE UROSCAN URODYNAMIC (K880504)Mct Medical, Inc.1988-06-17
MDL-1 LASERTRIPTER (K880503)Candela Laser Corp.1988-06-17
1/2 CM REAR TIP EXTENDER (RTE) (K882297)American Medical Systems, Inc.1988-06-17
AT EASE STRESS PAD (K880454)Hospital Specialty Co.1988-06-16
UROLOGICAL CATHETER (K881646)Coeur Laboratories, Inc.1988-06-16
SPEC 5* SUPRAPUBIC CATHETER (K881097)Porges Corp.1988-06-03
ENTERA* ENTERAL FEEDING BAG (K881162)Smash Ent., Inc.1988-06-03
INTRO-REDUCER (NASOGASTRIC TUBE) (K875232)Health Improvement Assoc.1988-06-02
DENVER PERITONEO-VENOUS SHUNT (K880401)Codman & Shurtleff, Inc.1988-05-31
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 (K880802)Medical Engineering Corp.1988-05-26
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 (K880801)Medical Engineering Corp.1988-05-26
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS (K880102)Baxter Healthcare Corp1988-05-26
KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE (K880850)Kmb Medical Products Co.1988-05-26
DENT SLEEVE MANOMETRIC CATHETER (K881310)Wilson-Cook Medical, Inc.1988-05-20
HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT (K881957)N-S Medical Products1988-05-20
EMERGENCY-CLEAN UP(TM) ECP (K880306)Cdc Products Corp.1988-05-20
NATIONAL-STANDARD NEEDLE HOLDER (K881956)N-S Medical Products1988-05-20
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR (K881004)Keymed, Inc.1988-05-12
PORGES URETERAL STENT (K881744)Bivona Medical Technologies1988-05-03
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER (K874154)Electro-Catheter Corp.1988-04-29
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA (K881290)Shiley, Inc.1988-04-27
DACOMED CYSTOMETER (K880391)Dacomed Corp.1988-04-27
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (K874084)National Medical Care, Medical Products Div., Inc.1988-04-27
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH (K881332)Baxter Healthcare Corp1988-04-27
FRESENIUS PURISTERIL 340 (TM) (K874573)Seratronics, Inc.1988-04-25
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