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Gastroenterology, Urology

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

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RecordFirmDate
FIBERSCOPE DISINFECTANT IRRIGATOR (K830026)Keymed, Inc.1983-01-14
LUNDIA 10-5-L PARRALLE FLOW DIALYZER (K823791)Gambro, Inc.1983-01-12
CAPILLARY FLOW DIALYZERS (K823826)Travenol Laboratories, S.A.1983-01-12
CATHETER HOLDER (K823818)Danek Medical, Inc.1983-01-09
STERILE, DISPOS. SPIKE PROTECTOR-5C4138 (K823777)Travenol Laboratories, S.A.1983-01-07
COBE HEMOCONCENTRATOR 1.3 (K823338)Cobe Laboratories, Inc.1983-01-07
URETHRAL PRESSURE PROFILE & TEMP. MODUL (K823561)Nihon Kohden America, Inc.1983-01-07
GAMMA STERILIZED CAPILLARY FLOW DIALYZ (K823778)Travenol Laboratories, S.A.1983-01-07
HOSPAL BLOOD LINES (K823707)Hospal Medical Corp.1983-01-05
FEMALE EXTERNAL URINARY APPLIANCE (K823450)Diamed Division Ill. Tool Works, Inc.1982-12-28
PEDIATRIC URINE COLLECTOR (K823411)Sage Products, Inc.1982-12-28
H 12 07 (K823589)Hospal Medical Corp.1982-12-22
AMICON DIAFILTERS 20 & 30 HEMOFILTERS (K823288)Amicon, Inc.1982-12-16
RENAFLO II (K823546)Renal Systems, Inc.1982-12-16
UROCOMP REMOTE CONTROL 1804 (K822916)Life-Tech Intl., Inc.1982-12-13
UNI-TIP COLOSTOMY IRRIGATION CONE (K823274)Howmedica Corp.1982-12-07
NEPHROSS, ANDANTE H.F. (K823375)Organon Teknika Corp.1982-12-07
GASTRIC LAVAGE KIT (K823195)Autovage1982-12-03
RIGHT ATRIAL CATHETER (K822964)Quinton, Inc.1982-11-30
1512M/F WIRE ELECTRODE NEEDLE SET (K823432)Life-Tech Intl., Inc.1982-11-30
INPERSOL PERITONEAL DIALSIS CYCLER SET (K823217)Abbott Laboratories1982-11-30
RIGHT ARTERIAL CATHETER (K822910)Quinton, Inc.1982-11-29
BED GUARD (K823276)T. S. Enterprises, Inc.1982-11-24
HEMAFLO BLOOD TUBING SETS (K823092)Cobe Laboratories, Inc.1982-11-22
DIA SCOPE (K822087)Exitec, Inc.1982-11-17
SIGMOIDOSCOPE, FLEXIBLE (K822765)Harvard Laboratories1982-11-17
DIALYSATE ADDITIVES-POWDER/LIQUID (K823103)Di-Chem, Inc.1982-11-17
ENTERAL NUTRITION 1 (K822879)Exco, Inc.1982-11-16
TRAVASORB NASOGASTRIC NASOINTESTINAL (K823082)Travenol Laboratories, S.A.1982-11-16
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL (K822711)Parker Laboratories, Inc.1982-11-03
EXTRACORPOREAL SINGLE NEEDLE MODULE (K822340)Extracorporeal Medical Specialities, Inc.1982-11-03
MODEL 700 GASTROREFLUX MONITOR/AMALYZER (K822815)Del Mar Avionics1982-10-22
PENTAX FC-38LA & FC-38SA COLONOFIBER (K822846)Pentax Precision Instrument Corp.1982-10-22
ENDOSCOPIC VIDEOSYSTEM (K822959)Eder Instrument Co, Inc.1982-10-22
INPERSOL-CAPD ADMINIS. SET TYPE DP (K822712)Abbott Laboratories1982-10-21
EXTENSION SET TYPE DP (K822658)Abbott Laboratories1982-10-21
FACE SHIELDS (K822004)Kelleher Corp.1982-10-20
DIALYZER REPROCESSING SYSTEM DRS-4 (K821863)Seratronics, Inc.1982-10-18
ARTERIO VENOUS SHUNT CANNULA & ADAPTORS (K822880)Renal Systems, Inc.1982-10-18
NEGATIVE PRESSURE ARTERIAL BLOOD LINE (K822796)Erika, Inc.1982-10-18
CCPD CYCLER SET W/5 PRONGED CONNECTOR (K822545)American Medical Products, Inc.1982-10-13
SAFE LOCK TITANIUM ADAPTER SET (K822550)American Medical Products, Inc.1982-10-13
CAPD SAFE LOCK TRANSFER SET (K822543)American Medical Products, Inc.1982-10-13
SAFE LOCK CATHETER S-3 (K822548)American Medical Products, Inc.1982-10-13
AMP CAPD UNISPIKE AMINISTRATION SET (K822551)American Medical Products, Inc.1982-10-13
CCPD CYCLER SET W/5 PRONGED SAFE LOCK (K822549)American Medical Products, Inc.1982-10-13
SAFE LOCK SEALING CAP L (K822544)American Medical Products, Inc.1982-10-13
EXTRAPURE REVERSE OSMOSIS WATER UNIT (K822385)Extracorporeal Medical Specialities, Inc.1982-10-13
SAFE LOCK SEALING CAPS (K822546)American Medical Products, Inc.1982-10-13
PEDI-TUBE PEDIATRIC FEEDING TUBE (K822875)Biosearch Medical Products, Inc.1982-10-13
COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (K822386)Hospal Medical Corp.1982-10-06
DISSCAP 080 (K822851)Hospal Medical Corp.1982-10-04
CIDEX*DIALYZER DISINFECTING SOLUTION (K822535)Surgikos, Inc.1982-09-30
NEEDLE CATHETER JEJUNOSTOMY KIT (K822565)Bio-Research Associates, Inc.1982-09-28
LITHOTRIPTOR ELECTRODE 4.5F (K822585)Monaghan Medical Corp.1982-09-28
ADHESIVE SPRAY #4050-4060 (K822307)The Healthcare Group Laboratories, Inc.1982-09-24
RETRIEVAL BALLOONS (K821818)American Endoscopy, Inc.1982-09-24
TRIEX-IH DIALYZER (K822738)Extracorporeal Medical Specialities, Inc.1982-09-24
SOLID STATE CONTINUOUS FLOW CONTROL (K822743)Widran Urological Group, Ltd.1982-09-24
RIWOLITH 2135 (K822644)R. Wolf Medical Instruments Corp.1982-09-21
DENVER PERITONEO-VENOUS SHUNT (DP-VS) (K822686)Denver Biomedicals, Inc.1982-09-21
ROMBEAU GASTROSTOMY-JEJUNAL TUBE (K822380)Hedeco1982-09-17
GASTRO VAGE SET FOR GASTRIC LAVAGE (K822228)Ackrad Laboratories1982-09-09
AUTOMATIC SPLICING DEVICE (K822025)E.I. Dupont DE Nemours & Co., Inc.1982-09-09
CAPD BELT (K822547)American Medical Products, Inc.1982-09-09
ARGYLE DUO-TUBE (K822631)Sherwood Medical Co.1982-09-09
NASO-GARD NASOGASTRIC TUBE HOLDER (K822443)American Pharmaseal Div. Ahsc1982-09-02
NEPHROSOL (K822244)Dialysis Systems, Inc.1982-09-02
HPF 100,200,300 CAPILLARY FLOW DIALYZ (K822485)Erika, Inc.1982-08-30
STERILE FOLEY CATHETERIZATION KITS (K821979)Medical Devices, Inc.1982-08-30
TS-000 ARTERIOVENOUS BLOOD TUBING SET (K822283)Extracorporeal Medical Specialities, Inc.1982-08-27
ENDOSCOPIC SPONGE CARRIER (K822194)Kelleher Corp.1982-08-27
ST. MARK'S RECTAL BIOPSY FORCEPS (K822401)Keymed, Inc.1982-08-27
ENDOSCOPIC SCLEROTHERAPY BALLOON (K821999)Retech1982-08-27
STERILE URETHRAL CATHETERIZATION SET (K821978)Medical Devices, Inc.1982-08-25
PIGTAIL STENTS (K821819)American Endoscopy, Inc.1982-08-20
ELECTRIC CORD FOR ENDOSCOPE (K822254)Kelleher Corp.1982-08-20
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE (K822225)Erika, Inc.1982-08-16
ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN (K822226)Erika, Inc.1982-08-16
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 (K822361)Travenol Laboratories, S.A.1982-08-16
LUNDIA 10-5 N PARALLEL FLOW DIALYZER (K822049)Gambro, Inc.1982-08-16
CF 1211 CAPILLARY FLOW DIALYZER CODE (K822395)Travenol Laboratories, S.A.1982-08-12
THE INFLATABLE PENILE PROSTHESIS (K821628)American Medical Systems, Inc.1982-08-10
PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A (K821974)Pentax Precision Instrument Corp.1982-08-10
CONPHAR SILICONE FEEDING TUBE (K821825)Conphar, Inc.1982-08-10
ASSURE-MALE EXTERNAL INCONTINCE CATHETER (K821848)Medical Design & Manufacturing Corp.1982-08-10
PIGTAIL NASAL CATHETERS (K821817)American Endoscopy, Inc.1982-08-10
SHIELY DUEL LUMEN SUBCLAVIAN CANNULA (K822134)Shiley, Inc.1982-08-03
UROGARD (K821829)Buckman Consultants1982-07-30
C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (K821328)Medionics International , Ltd.1982-07-28
U-200 BAG (K821854)Medical Technologies of Georgia1982-07-22
MCPARLAND SCALP VEIN CATHETER (K821001)Renal Systems, Inc.1982-07-22
U-100 BAG (K821853)Medical Technologies of Georgia1982-07-22
DYNACOR URETHRAL CATHETER TRAY (K821970)Medline Industries, Inc.1982-07-21
LAVAGING CATHETERS (K822061)American Endoscopy, Inc.1982-07-20
MCSCK638 CATHETER IN A TRAY (KIT) (K821955)Medcomp1982-07-14
MCSCK838 CATHETER IN A TRAY (KIT) (K821954)Medcomp1982-07-14
UROCOMP MODEL 1404 (K821939)Life-Tech Intl., Inc.1982-07-13
CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP (K821906)Corpak Medsystems1982-07-13
CLIRANS HOLLOW FIBER DIALYZERS (K820524)Terumo Medical Corp.1982-07-08
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