| SORIN PULSE GENERATOR, MODEL #LIT-214 (K801640) | Bentley Laboratories, Inc. | 1980-10-03 |
| F/LS MCA APPLICATION SOFTWARE (K801456) | Instrumentation Laboratory CO | 1980-10-03 |
| CORROSION PROOF SNAP ECG CONNECT WIRES (K802236) | Custom Cardio Components | 1980-10-03 |
| OHIO THORACIC SUCTION REGULATOR (K802285) | Ohio Medical Products | 1980-10-03 |
| URINE COLLECTION CONTAINERS, #3600 &3610 (K801786) | The Healthcare Group Laboratories, Inc. | 1980-09-30 |
| NU-VISION DISP. OPHTHALMIC DRESSING TRAY (K801822) | Summit Optics, Inc. | 1980-09-30 |
| CONICAL TIPPED CENTRIFUGE TUBE 15M (K802210) | Scientific Specialties, Inc. | 1980-09-26 |
| PROT-A-TRAC (K802072) | Robert I. Branick, M.D. | 1980-09-26 |
| DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC (K802090) | Draeger Medical, Inc. | 1980-09-26 |
| DISPOSABLE NURSES CAP (K802186) | Anago, Inc. | 1980-09-26 |
| PEDIWET=GUAZE IMPREGNATED WITH PETROL (K802007) | Pollak (Intl.), Ltd. | 1980-09-26 |
| COMPUTER ECG TERMINAL (K802272) | Compumed, Inc. | 1980-09-26 |
| AIR COMPRESSOR ADAPTOR KIT (K802253) | Hudson Oxygen Therapy Sales Co. | 1980-09-26 |
| ARGYLE SUCTION CANISTER W/DISP. LINER (K802174) | Sherwood Medical Co. | 1980-09-26 |
| CLEAN-AIR POLLUTION REDUCTION SYSTEM (K802067) | Porter Instrument Co., Inc. | 1980-09-26 |
| MODEL 203S CLINICAL CHEMISTRY ANALYZER (K801889) | Gilford Instrument Laboratories, Inc. | 1980-09-26 |
| PROGRAMALITH #'S 221, 222, 221A & 222A (K801978) | Pacesetter Systems | 1980-09-26 |
| STIFF STYLETS (K802076) | Cardiac Pacemakers, Inc. | 1980-09-26 |
| BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM (K802198) | Biometric Analysis Group, Inc. | 1980-09-26 |
| HEMO-CATH II KIDNEY DIALYSIS CATHETER (K801966) | Medical Components, Inc. | 1980-09-26 |
| DUPONT ACALACTIC ACID (LA) TEST (K802064) | E.I. Dupont DE Nemours & Co., Inc. | 1980-09-26 |
| ECG RECALL & EDIT PRODUCT VERSION-A3601 (K802103) | General Electric Co. | 1980-09-26 |
| DISARP ORIGINAL (K802248) | Unoplast A/S | 1980-09-26 |
| CARDIOTRAK (K802089) | Cardiac Pacemakers, Inc. | 1980-09-26 |
| KEITHLEY LYMPHOCYTE DEPLETION CART (K801899) | Keithley Development Co. | 1980-09-26 |
| EDP 1200 SECTOR SCANNER OPTION (K801656) | Unirad Corp. | 1980-09-26 |
| IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN (K802028) | Telectronics, Inc. | 1980-09-26 |
| DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM (K801948) | Technicare Corp. | 1980-09-26 |
| IMMUNODIFFUSION REAGENTS/SEROLOGICAL (K802129) | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| BAKER DIAG. ULTRARATE CO2 REAGENT KIT (K802035) | J.T. Baker Chemical Co. | 1980-09-26 |
| URIHESIVE STRIPS (K802173) | E. R. Squibb & Sons, Inc. | 1980-09-26 |
| SCANLAN STERNUM NEEDLE-SUTURE (K801976) | Scanlan Intl., Inc. | 1980-09-26 |
| HEARTWATCH (K800519) | D. Jenkins | 1980-09-26 |
| AUTO SECTOR SCANNER (K801655) | Unirad Corp. | 1980-09-26 |
| AMES TDA PHENOBARBITAL TEST (K802255) | Miles Laboratories, Inc. | 1980-09-26 |
| FIBRI QUIK (K802117) | General Diagnostics | 1980-09-26 |
| RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. (K801825) | Renal Systems, Inc. | 1980-09-26 |
| HEMOCATH I KIDNEY DIALYSIS CATHETER (K801968) | Medical Components, Inc. | 1980-09-26 |
| DENTLOID (K802189) | U.S. Shizai Corp. | 1980-09-26 |
| RIONET HEARING AID HB-69C (K802053) | Rion Acoustic Instruments, Inc. | 1980-09-26 |
| BOUNDARY SINGLE-USE DRAPE (K802148) | Procter & Gamble Mfg. Co. | 1980-09-26 |
| OXFORD INTENSIVE CARE PATIENT MON. SYS (K802033) | Oxford Medilog, Inc. | 1980-09-26 |
| BIFOCAL 2 8200 SERIES (A,B C,D) (K800379) | American Pacemaker Corp. | 1980-09-26 |
| CLINETICS PCA COLUMN (K801306) | Clinetics Corp. | 1980-09-26 |
| IMMUNO. IDENTIFICATION OF H. CAPSULATUM (K802130) | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| ETHICON RETRACTION TAPE (K801699) | ETHICON, Inc. | 1980-09-26 |
| BR 2002 X-RAY GENERATOR SYSTEM (K801808) | Valmet Indus. Mach. & Prod., Inc. | 1980-09-26 |
| ISOLETTE INCUBATOR C-100 (K802126) | Narco Air-Shields | 1980-09-26 |
| LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (K801909) | J.T. Baker Chemical Co. | 1980-09-26 |
| GABBAY-FRATER SUTURE GUIDE (K802093) | Howmedica Corp. | 1980-09-26 |
| RENAFLO HOLLOW FIBER DIALYZERS #MP 140 (K801826) | Renal Systems, Inc. | 1980-09-26 |
| BOUNDARY SINGLE-USE DRAPES (K802247) | Procter & Gamble Mfg. Co. | 1980-09-26 |
| TENDER-SORB DRAIN SPONGES (K802225) | Kendall Research Center | 1980-09-26 |
| MEDTRONIC MODEL 69575 (K800944) | Medtronic Vascular | 1980-09-26 |
| RENAFLO HOLLOW FIBER DIALYZER #100.1 (K801827) | Renal Systems, Inc. | 1980-09-26 |
| IMMUNODIFFUSSION REAGENTS/SEROLOGICAL (K802128) | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| EMBRIA-CK (K801728) | Intl. Immunoassay Laboratories, Inc. | 1980-09-26 |
| HS10 PORTABLE OPERATING ROOM MONITOR (K802184) | Medtel Pty. , Ltd. | 1980-09-26 |
| URIHESIVE SYSTEM (K802172) | E. R. Squibb & Sons, Inc. | 1980-09-26 |
| CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (K792377) | Environmental Chemical Specialties | 1980-09-26 |
| 2M8101 HEATED LIQUID LEVEL CONTROLLER (K802144) | Travenol Laboratories, S.A. | 1980-09-26 |
| RION DIAGNOSTIC AUDIOMETER (K802207) | Rion Acoustic Instruments, Inc. | 1980-09-26 |
| HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH (K800857) | Helena Laboratories | 1980-09-26 |
| MICRO-FLOW SPECTROPHOTOMETER CL-720 (K801957) | Shimadzu Precision Instruments, Inc. | 1980-09-26 |
| BALLOON RETENTION CHEST CATHETER (K802025) | Loseff Medical Designers, Ltd. | 1980-09-26 |
| MICRO-BOND HI-LIFE PROCELAIN & VIVERE (K802235) | Howmedica Corp. | 1980-09-26 |
| MEDCOMP FEMORAL VEIN CATHETER (K801967) | Medical Components, Inc. | 1980-09-26 |
| 3M HI-STRENGTH MED. TAPE #1534 (K802242) | 3M Company | 1980-09-26 |
| 2C 7140 HEATED HUMIDIFER CANNISTER (K802145) | Travenol Laboratories, S.A. | 1980-09-26 |
| NORDICLAB PROSTATIC ACID PHOSPHATASE RIA (K801988) | Nordiclab Intl. | 1980-09-26 |
| SHERWOOD VENTILATORY MUSCLE TRAINER (K802165) | Sherwood Medical Co. | 1980-09-26 |
| HALL ARTERIAL OSCILLATOR (K801063) | American Sterilizer Co. | 1980-09-26 |
| ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM (K801451) | Medical, Inc. | 1980-09-26 |
| API-CTS STREPTOCOCCUS (K801951) | Analytical Products, Inc. | 1980-09-26 |
| BOUNDARY SINGLE-USE DRAPES (K802192) | Procter & Gamble Mfg. Co. | 1980-09-26 |
| RHYTIDOMETER (K801939) | Aztec Medical Products, Inc. | 1980-09-26 |
| SECHRIST SERIES 3500 AIR-OXYGEN MIXER (K802226) | Sechrist Industries, Inc. | 1980-09-26 |
| MICROLAB M-MICROPROCESSOR DILUTER/DISP (K801913) | Hamilton Co. | 1980-09-26 |
| DATA-ZYME UREA NITROGEN REAGENT SET (K802061) | Data Medical Associates, Inc. | 1980-09-26 |
| AULD BAGGER KIT (K802081) | Modern Medical Systems Co. | 1980-09-26 |
| STOPCOCK 2-WAY, 3-WAY & 4-WAY (K802258) | Stanco Medical, Inc. | 1980-09-26 |
| UV URIC ACID STANDARDS (K801501) | The Dow Chemical Co. | 1980-09-26 |
| BENTLEY THEROMODILUTION CATHETER #BTD-7F (K802133) | Bentley Laboratories, Inc. | 1980-09-26 |
| ANASTIM II TRANSCUTANEOUS ELECTRICAL (K802227) | Biostim, Inc. | 1980-09-26 |
| PROPHYLACTIC W/SPERMICIDAL LUBRICANT (K802354) | Schmid Laboratories, Inc. | 1980-09-25 |
| START IT WITH & WITHOUT I.V. CATH. UNIT (K801537) | Pioneer Viggo, Inc. | 1980-09-19 |
| IMPLANTABLE PROGRAM. CARDIAC PACEMAKER (K800793) | Telectronics, Inc. | 1980-09-18 |
| LEUKOCYTE VOL. ANALYSIS APPARATUS (K802208) | Coulter Electronics, Inc. | 1980-09-17 |
| CAULK PRISMA-LITE (K801588) | Dentsply Intl. | 1980-09-16 |
| ARROW POSITIVE PLACEMENT CON/EPIDURAL AN (K801912) | Arrow Intl., Inc. | 1980-09-16 |
| INTRACRANIAL PRESSURING MONITORING SYST. (K802100) | Pudenz-Schulte Medical Research Corp. | 1980-09-16 |
| ARIA II 125- I-ESTRIOL SYSTEM (K801735) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-09-16 |
| WAKO HDL CHOLESTEROL TEST (K801834) | Wako Pure Chemical Industries, Ltd. | 1980-09-16 |
| NIMETIC-DISPERS (K802049) | Espe Dental Products | 1980-09-16 |
| PROFILE SWAB CAT.#5273 & 5274 (K802004) | Pollak (Intl.), Ltd. | 1980-09-16 |
| C-SPLINT (K802104) | Cutter Laboratories, Inc. | 1980-09-16 |
| RAMI TAN ULTRAVIOLET B BOOTH (K801752) | Rami-Tan | 1980-09-16 |
| STERILE GUAZE SWABS CAT.#301-420 (K802022) | Pollak (Intl.), Ltd. | 1980-09-16 |
| ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE (K802125) | Dentsply Intl. | 1980-09-16 |
| NORDICLAB FERRITIN IRMA TEST (K801989) | Nordiclab Intl. | 1980-09-16 |