| LUMEN-4 URODYNAMIC CATHETER (K833628) | Surgitek | 1983-11-28 |
| ASAHI HOLLOW FIBER KIDNEYS, EXCEL (K833150) | Asahi Medical Co., Ltd. | 1983-11-15 |
| MUTO BRUSH (K833330) | Microvasive | 1983-11-14 |
| FOAM HELMET - USE W/ESOPHAGEAL TAMPONA (K832859) | Inmed Corp. | 1983-11-14 |
| ASPIRATION & IRRIGATION CATHETER (K833331) | Microvasive | 1983-11-14 |
| C-FLEX PENROSE DRAINAGE TUBE (K833061) | Concept, Inc. | 1983-11-07 |
| HEMO-DIAL (K832866) | Cmi Pharmaceuticals, Inc. | 1983-11-03 |
| ANGIOSCOPY CATHETER (K832698) | American Edwards Laboratories | 1983-11-03 |
| MOTILITY MEASUREMENT SYS MMS-100 (K832869) | Narco Bio-Systems | 1983-10-31 |
| HOBBS MEDICAL GRASPING FORCEPS (K833125) | Hobbs Medical, Inc. | 1983-10-31 |
| SECURITY STRETCH BRIEF-MEDICAL (K833245) | Mb Products, Ltd. | 1983-10-31 |
| FLEXIFLO ENTERAL FEEDING TUBE (K832966) | Abbott Laboratories | 1983-10-31 |
| LEIDER FEEDING TUBE W/HYDROMER LUBR (K833293) | Biosearch Medical Products, Inc. | 1983-10-31 |
| ENDOSCOPIC OVERTUBE (K833268) | Mill-Rose Laboratory | 1983-10-31 |
| HPR HOME PATIENT RENATRON (K833181) | Renal Systems, Inc. | 1983-10-27 |
| SURGIKEK PENILE PROSTHESIS TAIL EXTEND (K832043) | Medical Engineering Corp. | 1983-10-20 |
| AUTOMATIC ENDOSCOPE (K832458) | American Endoscopy, Inc. | 1983-10-20 |
| SILICONE-SILVER PENILE PROSTHESIS-ESK (K830667) | Dacomed Corp. | 1983-10-20 |
| GASTRIC SUMP TUBES (K833054) | Medovations, Inc. | 1983-10-19 |
| PEDIATRIC ILLUMINATING URETERAL (K832807) | Van-Tec, Inc. | 1983-10-19 |
| DEFLECTING GUIDE WIRE (K833242) | Van-Tec, Inc. | 1983-10-19 |
| URETERAL DILATION SET (K832808) | Van-Tec, Inc. | 1983-10-14 |
| LUNDIA 10-2-L PARALLEL PLATE HEMODIALY (K832894) | Gambro, Inc. | 1983-10-14 |
| URO-TEX MALE EXTERNAL CATHETER (K832450) | Sierra Laboratories, Inc. | 1983-10-14 |
| GRAVITY ENTERAL FEEDING SET (K832927) | Medical Connections | 1983-10-14 |
| MICROSTAR VCI (K831766) | Medionics International , Ltd. | 1983-10-14 |
| CLOSED SYS. DRAINAGE BAGS & TRAYS (K832822) | Medline Industries, Inc. | 1983-10-14 |
| NEPHROSS PRESTO (K832666) | Organon Teknika Corp. | 1983-10-14 |
| URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN (K832915) | Surgitek | 1983-10-14 |
| SHERIDAN/LEVI-A-SUMP (K832196) | Sheridan Catheter Corp. | 1983-10-14 |
| TOP DISPOS. INFUSION SET/HEMODIALY (K832623) | Top Surgical Manufacturers Co. | 1983-10-14 |
| DUAL FLOW NEEDLE (K832136) | Travenol Laboratories, S.A. | 1983-10-14 |
| DIALYZER PREPARATION SYS DPS-4 (K832230) | Seratronics, Inc. | 1983-10-14 |
| THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 (K831424) | Extracorporeal Medical Specialities, Inc. | 1983-10-14 |
| MICROSTAR VC1 VOLUMETRIC CYCLER (K832141) | Medionics International , Ltd. | 1983-10-14 |
| SINGLE PATIENT SYS. II MODEL DM-450 (K832053) | Extracorporeal Medical Specialities, Inc. | 1983-09-29 |
| STERILE FLUID PRODUCING UNIT #EP550 (K832040) | American Cystocope Makers, Inc. | 1983-09-29 |
| TISSUE FORCEPS (K831663) | Medcare Products | 1983-09-26 |
| BIOSPAL 1200S (K832659) | Hospal Medical Corp. | 1983-09-20 |
| BIOSPAL 3000 S (K832645) | Hospal Medical Corp. | 1983-09-20 |
| CATHETER CARE TRAY (K832389) | Inmed Corp. | 1983-09-19 |
| UROTRACK PLUS (K832526) | Vital Metrics, Inc. | 1983-09-19 |
| GAMMA STERIL. CAPILLARY FLOW DIALY-G15 (K832663) | Travenol Laboratories, S.A. | 1983-09-12 |
| CURITY CATHETER STRAP (K832692) | The Kendal Co. | 1983-09-12 |
| BALLOON DILATION HELICAL STONE EXTRACT (K831875) | Vpi | 1983-09-12 |
| CONVEEN LEG BAG W/TUBE-DRAINAGE BAG (K832537) | Telcam Medical Devices, Inc. | 1983-09-12 |
| URODYNAMIC ANALYZER (K831788) | C.R. Bard, Inc. | 1983-09-12 |
| ENTERNAL FEEDING TUBE (K832293) | Concept, Inc. | 1983-09-12 |
| FOUR LUMEN BLAKEMORE TUBE (K832672) | Inmed Corp. | 1983-09-12 |
| CONVEEN DRIP COLLECTOR/NET PANTS (K832489) | Telcam Medical Devices, Inc. | 1983-09-12 |
| STERILE FOLEY CATHETERS & UROLOGICAL (K831743) | Electromedics, Inc. | 1983-09-12 |
| VIVONEX TUNGSTEN TIP TUBE-WOUND (K831969) | Norwich Eaton Pharmaceuticals, Inc. | 1983-09-01 |
| VIVONEX TUNGSTEN TIP TUBE-BRAIDED (K831968) | Norwich Eaton Pharmaceuticals, Inc. | 1983-09-01 |
| VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE (K831971) | Norwich Eaton Pharmaceuticals, Inc. | 1983-09-01 |
| JEJUNOSTOMY KIT (K831847) | Accu-Line | 1983-08-31 |
| ENEMA TUBE (K832501) | Cone Instruments, Inc. | 1983-08-31 |
| VISI-FLOW IRRIGATOR (K832299) | Convatec, A Division of E.R. Squibb & Sons | 1983-08-26 |
| CLIRANS TAF06 HOLLOW FIBER DIALYZER (K832252) | Terumo Medical Corp. | 1983-08-26 |
| HEMOPERFUSION SYSTEM TP-400 (K831029) | Extracorporeal Medical Specialities, Inc. | 1983-08-26 |
| BLOOD TUBING SET (K832103) | Lee Medical Intl., Inc. | 1983-08-12 |
| FEEDING TUBE PLACEMENT STYLET (K831840) | Biosearch Medical Products, Inc. | 1983-08-12 |
| GASTROSTOMY FEEDING SET (K831631) | Plasco, Inc. | 1983-08-12 |
| AXIOM FEEDING GASTRO TUBE (K831823) | Axiom Medical, Inc. | 1983-08-12 |
| MORHEL CLOSED URINARY DRAINAGE SET (K831622) | Morhel Mexicana | 1983-08-11 |
| SURGITEK PERCUTANEOUS ARNEGRADE SILITEK (K831857) | Medical Engineering Corp. | 1983-08-11 |
| PENTAX FG-34JA GASTROFIBERSCOPE (K832007) | Pentax Precision Instrument Corp. | 1983-08-11 |
| EMPTY DIALYSATE CONTAINER (K831689) | Delmed, Inc. | 1983-08-11 |
| FOLEY-TEMP (K831567) | Mallinckrodt Critical Care | 1983-08-10 |
| URINE BAG SYSTEM (K831796) | I M, Inc. | 1983-08-08 |
| IMPROVED SILICATH SILICONE ELASTOMER (K832165) | Travenol Laboratories, S.A. | 1983-08-08 |
| AMS MALLEABLE PENILE PROSTHESIS (K831660) | American Medical Systems, Inc. | 1983-08-08 |
| COMPUDIAL/KP-1 (K831132) | Computer Dialysis Systems, Inc. | 1983-08-08 |
| GAMMA STERILIZED CAPILLARY FLOW DIALYZ (K831940) | Travenol Laboratories, S.A. | 1983-08-08 |
| PRESSURE MONITOR & CONTROL UNIT APC-02A (K831402) | Parker Hannifin Corp. | 1983-08-08 |
| PENTAX FD-34A DUODENOFIBERSCOPE (K832006) | Pentax Precision Instrument Corp. | 1983-08-01 |
| COAXIAL BALLOON URETHRAL DILATOR (K831384) | Thomas J. Fogarty, M.D. | 1983-07-26 |
| EXTERNAL INCONTINENCE CATHETER TRAVEL (K832106) | Plasco, Inc. | 1983-07-19 |
| INFUSION PUMP (K831953) | Cryosan, Inc. | 1983-07-19 |
| COLOSTOMY BAG (K830841) | C & D Colostomy Pad Corp. | 1983-07-19 |
| NEONATAL NASOGASTRIC FEEDING TUBE- (K831328) | Corpak Medsystems | 1983-07-19 |
| LEG BAG EXTENTION TUBE-STERILE (K832107) | Plasco, Inc. | 1983-07-19 |
| STOMACH TUBE LEVIN TUBE (K831974) | Medline Industries, Inc. | 1983-07-18 |
| EXTERNAL INCONTINENCE CATHETER TAKE-HOME (K832109) | Plasco, Inc. | 1983-07-18 |
| VIVONEX TUNGSTEN TIP TUBE-MONOFILA- (K831970) | Norwich Eaton Pharmaceuticals, Inc. | 1983-07-18 |
| MODEL #27224P CONTINUOUS FLOW PUMP (K832009) | KARL STORZ Endoscopy-America, Inc. | 1983-07-18 |
| EXTERNAL INCONTINENCE CATHETER SET-NON (K832108) | Plasco, Inc. | 1983-07-18 |
| DOBBHOFF FEEDING TUBE W/HYDROMER LUB (K831868) | Biosearch Medical Products, Inc. | 1983-07-12 |
| BROOKS SCLEROTHERAPY CUFF (K823475) | Inmed Corp. | 1983-07-12 |
| HEMOCLAV VENOUS CATHETER (K831801) | Exo, Inc. | 1983-07-07 |
| ARTIFICIAL KIDNEY BLOOD CIRCUIT (K831770) | Eiken Kizai Co., Ltd. | 1983-07-07 |
| TEFLON FEMORAL CATHETER MWI 100,10 & (K831828) | Med-West, Inc. | 1983-07-07 |
| SPORIDIDIN-D COLD STERILIZING/SOLUTION (K830722) | Sporicidin Intl. | 1983-06-30 |
| HAEMOLYTE SOLUTION (K831409) | Dialysis Clinic, Inc. | 1983-06-30 |
| PLASMA THERAPY TUBESET-E100 SERIES (K831747) | Parker Hannifin Corp. | 1983-06-30 |
| GF-180-L HOLLOW FIBER HEMODIALYSIS (K831606) | Gambro, Inc. | 1983-06-24 |
| CAPD - CATHETER ADAPTER (K831716) | American Mcgaw | 1983-06-24 |
| SURGITEK NEPHROSTENT KIT (K831446) | Mec/Surgitek Products | 1983-06-22 |
| URETERAL STONE EXTRACTOR CATHETER (K831244) | American Edwards Laboratories | 1983-06-17 |
| LEG DRAINAGE BAG STRAP BK6011 (K831553) | Fred Sammons, Inc. | 1983-06-16 |
| UNIVERSAL CANNULA (K830719) | Acufex Microsurgical, Inc. | 1983-06-16 |