| FLOW-DIRECTED HEPARIN COATED THERMODIL (K832957) | Sorensen Research | 1983-09-29 |
| BIOCHECK PEC-108 PROGRAM-PULSE MONITOR (K831752) | Biotechnology, Inc. | 1983-09-29 |
| CORONARY ANASTOMOSIS MARKING SYSTEM (K832806) | Biotrac Laboratories | 1983-09-29 |
| SHILEY 3L CARDF PLUS (K832811) | Shiley, Inc. | 1983-09-20 |
| PRE-BYPASS FILTER #EC-PBF SERIES (K832594) | Gish Biomedical, Inc. | 1983-09-20 |
| ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. (K832058) | Parke-Davis Co. | 1983-09-12 |
| AIR SHIELDS AS-100 MONIORING SYS-AS105 (K831430) | Narco Scientific | 1983-09-12 |
| BIOFLOW (K831422) | Bomed Medical Mfr., Ltd. | 1983-09-12 |
| GASLINE FILTER #GF-10 (K832411) | American Bentley | 1983-09-12 |
| BOMED BIOCON (K831421) | Bomed Medical Mfr., Ltd. | 1983-09-12 |
| C TEC SERIES 9000 E.C.G. ELECTRODE (K831977) | Speywood Medical, Ltd. | 1983-09-09 |
| HANCOCK PERICARDIAL PATCH (K830863) | Extracorporeal Medical Specialities, Inc. | 1983-08-31 |
| RAPID ATRIAL PACER (K831381) | Seamed Corp. | 1983-08-31 |
| EMBOLECTOMY CATHETER (K832023) | Bionomy, Inc. | 1983-08-31 |
| VESSEL DILATOR (K832595) | Abbott Laboratories | 1983-08-31 |
| PERCUTANEOUS INTRODUCER KIT (K831636) | Accu-Line | 1983-08-24 |
| IMPLANTABLE PROGRAM. CARDIAC PULSE GEN (K831771) | Telectronics, Inc. | 1983-08-16 |
| VASCULAR GRAFT/BIFURCATED/FEP-RINGED (K830806) | W. L. Gore & Associates, Inc. | 1983-08-13 |
| ELECTRODE LEADS 030-267 & 030-268 (K832110) | Telectronics, Inc. | 1983-08-12 |
| ELECTRONIC BLOOD PRESS. METER-ZH-820P (K832075) | Panasonic Co. Div. Matsu Elec. Corp. America | 1983-08-12 |
| FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE (K831659) | American Edwards Laboratories | 1983-08-12 |
| CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI (K832124) | Med-West, Inc. | 1983-08-12 |
| AMPLATZ HEPARIN COATED CATHETER (K832178) | Cook, Inc. | 1983-08-12 |
| DISPOS. ABODOMINAL RETRACTING PAD (K831130) | Product Development Corp. | 1983-08-12 |
| DISP. TRANSDUCER W/MONITORING KIT TRANS (K831506) | Sorensen Research | 1983-08-12 |
| VARIOUS CARDIOVASCULAR SURGICAL DEVICE (K831769) | Research Industries Corp. | 1983-08-12 |
| PRESSURE MONITORING IV BOTTLE CAP (K831867) | Alto Development Corp. | 1983-08-12 |
| ELECATH BALTHERM TLC THERMAL DILUTION (K831945) | Electro-Catheter Corp. | 1983-08-12 |
| PHYSIOLOGICAL MONITOR #902 (K831578) | Novametrix Medical Systems, Inc. | 1983-08-12 |
| UNIPOLAR-E ENDOCARDIAL TINED LEAD (K832245) | Cook Pacemaker Corp. | 1983-08-12 |
| EXTERNAL VALVE FUNCTION BLOCK (K830914) | Honeywell, Inc. | 1983-08-12 |
| INTRACARDIA SUCKERS (K831759) | Research Industries Corp. | 1983-08-12 |
| BIOELECTRICAL IMPEDANCE ANALYZER #101 (K830292) | Rjl Systems, Inc. | 1983-08-12 |
| BLOOD PRESSURE MONITORING KITS,WALRUS (K830754) | Medical Parameters, Inc. | 1983-08-12 |
| LIFELINE PACING LEADS #471-07 &09 (K832409) | Intermedics, Inc. | 1983-08-12 |
| MODEL F UNIPOLAR ENDOCARDIAL LEAD- (K832255) | Cook Pacemaker Corp. | 1983-08-12 |
| PACELINE PATIENT TRANSMITTER MODEL 324 (K831443) | Pacesetter Systems | 1983-08-12 |
| HR 100T (K831955) | Thought Technology , Ltd. | 1983-08-11 |
| CARDIVAN BLOOD PRESSURE MONITOR (K830682) | Paramed Technology, Inc. | 1983-08-11 |
| EDSLAB PRESSURE GAUGE (K832323) | American Edwards Laboratories | 1983-08-11 |
| PANASONIC MODEL EW-213 (K831151) | Panasonic Co. Div. Matsu Elec. Corp. America | 1983-08-11 |
| DISPOSABLE PRESSURE TRANSDUCER#14004195 (K831698) | Norton Performance Plastics Corp. | 1983-08-11 |
| CARDIOPLEGIA RESERVOIR-#500926 (K831966) | American Bentley | 1983-08-11 |
| UNIVERSAL CORONARY CANNULA (K831330) | Possis Medical, Inc. | 1983-08-10 |
| VENOUS CATHETER (K832064) | Cardio Search, Inc. | 1983-08-08 |
| MODEL 327T UNIPOLAR CARDIAC PULSE GEN (K832052) | Cook Pacemaker Corp. | 1983-08-08 |
| PROSTHETIC RINGS #4400 MITRAL & 4500 (K831949) | American Edwards Laboratories | 1983-07-29 |
| LIFESTAT 200 (K831232) | Physio-Control Corp. | 1983-07-28 |
| UNICUFF-BLOOD PRESSURE CUFF (K831001) | Frontier Products | 1983-07-28 |
| AMBULATORY ECG EVENT RECORDER (K830907) | Brentwood Instruments, Inc. | 1983-07-28 |
| UNIVERSAL LEVEL SENSOR (K831879) | 3M Health Care, Sarns | 1983-07-26 |
| TEMP. BIPOLAR EPICARDIAL LEAD (K831645) | Cordic Corp. | 1983-07-26 |
| MEDTRONIC MODELS 4012 & 4512 (K832099) | Medtronic Vascular | 1983-07-26 |
| IMPLANTABLE CARDIAC PACING LEADS (K831767) | Oscor, Inc. | 1983-07-26 |
| CARDIO ARRHYTHMIA TRANSMITTER C.A.T (K830903) | Cardio Technology , Ltd. | 1983-07-26 |
| PM-3 (K831750) | Delta Medical Industries | 1983-07-26 |
| THE BLOOM STETHOSCOPE (K830796) | Stethophonics, Inc. | 1983-07-19 |
| PECGASYS REMOTE TRANSMISSION UNIT (K831092) | Datamedix | 1983-07-19 |
| COMPRESSAR DISPOSABLE DISC (K831337) | Instromedix, Inc. | 1983-07-19 |
| VASCULAR GRAFT PROSTHESIS EXPANDED MICR (K830543) | Impra, Inc. | 1983-07-19 |
| GP-303 (K831583) | Hirata Sangyo Co. USA, Inc. | 1983-07-19 |
| CATHETER INSERTION TRAYS, VARIOUS #'S (K831807) | American Pharmaseal Div. Ahsc | 1983-07-18 |
| APNEA/BRADYCARDIA MONITOR HB 95 (K830666) | Harvey-Bostwick, Inc. | 1983-07-18 |
| PERCUTANEOUS CATHETER INSERTION TRAY (K831729) | American Pharmaseal Div. Ahsc | 1983-07-18 |
| WEDGE PRESSURE CATHETER (K830604) | Plasmedics, Inc. | 1983-07-18 |
| WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD (K831705) | C.R. Bard, Inc. | 1983-07-18 |
| HYPER-HYPOTHERMIA UNIT HYPO 10-200 (K831677) | Gambro, Inc. | 1983-07-18 |
| STAINLESS STEEL GUIDE WIRE (K831839) | Quinton, Inc. | 1983-07-18 |
| CONTINUOUS FLUSH DEVICE (K831730) | American Pharmaseal Div. Ahsc | 1983-07-18 |
| MICROVEL DOUBLE VELOUR SUPPORTED 100 (K822633) | Meadox Medicals, Div. Boston Scientific Corp. | 1983-07-12 |
| COMMAND ULTRA II (K831216) | Cardiac Pacemakers, Inc. | 1983-07-12 |
| LEATHER VALVE CUTTER (K831455) | American V. Mueller | 1983-07-07 |
| OMAR (K830915) | Oxford Medilog, Inc. | 1983-07-07 |
| VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR (K830916) | Bib, Inc. | 1983-07-07 |
| CORONARY GUIDING CATHETER-MODIFIED (K831563) | Advanced Cardiovascular Systems, Inc. | 1983-06-30 |
| ARGYLE DUAL STAGE VENOUS RETURN CATH. (K831332) | Sherwood Medical Co. | 1983-06-30 |
| MODEL TP THERMISTOR PROBE (K831528) | Scimed Life Systems, Inc. | 1983-06-30 |
| CCS MODEL SJ-103 IMPLANTABLE ATRIAL (K831529) | Cardiac Control Systems, Inc. | 1983-06-30 |
| CARDIOTOMY FILTER (K830634) | Texas Medical Products, Inc. | 1983-06-30 |
| DINAMAP VITAL SIGNS MONITOR #1846 (K831515) | Critikon Company, LLC | 1983-06-30 |
| AORTIC ROOT CANNULA W/INTEGRAL PRESS (K831591) | Dlp, Inc. | 1983-06-30 |
| SONTEK INFUSION CATHETER (K831562) | Sontek Corp. | 1983-06-30 |
| ACCU-FLUSH (K831637) | Accu-Line | 1983-06-30 |
| CORONARY INFUSION CATHETER (K831717) | Advanced Cardiovascular Systems, Inc. | 1983-06-30 |
| GOULD MODEL IM3000-IM3100 BATTERY POWER (K830885) | Gould, Inc. | 1983-06-22 |
| UNIVERSAL MEDDARS SYSTEM (K830791) | Electronics For Medicine, Inc. | 1983-06-22 |
| CIRCA MED TWO-CHANNEL (K830830) | Circadian, Inc. | 1983-06-18 |
| VASCULAB BLOOD PRESSURE CUFF (K831393) | Medasonics, Inc. | 1983-06-16 |
| CENTRAL STATION DISPLAY/RECORDER MATRIX (K830517) | Marquette Electronics, Inc. | 1983-06-15 |
| METAL-BACKED ACETABULAR CUP (K831479) | Dow Corning Corp. Healthcare Industries Materials | 1983-06-15 |
| COMMAND ULTRA I (K831161) | Cardiac Pacemakers, Inc. | 1983-06-15 |
| QUIK-SILVER RESTING ECG ELECTRODE (K830655) | Quinton, Inc. | 1983-06-15 |
| THERMODILUTION CARDIAC OUTPUT COMPUTER- (K830892) | American Edwards Laboratories | 1983-06-15 |
| BIO-PROBE SYSTEM-BLOOD FLOW PROBE (K830858) | Bio Medicus, Inc. | 1983-06-08 |
| VITAL SIGNS MONITOR 2 (K830587) | Physio-Control Corp. | 1983-06-08 |
| LOW PROFILE STEERABLE BALLOON DILATA (K831403) | Advanced Cardiovascular Systems, Inc. | 1983-06-08 |
| LS-1 PORTABLE BLOOD PRESSURE COMPUTER (K830713) | Vita-Stat Medical Services, Inc. | 1983-06-08 |
| ANGIOGRAPHY KIT W/ADDIT. COMPONENTS (K831509) | Mallinckrodt Critical Care | 1983-06-08 |
| UNIPOLAR ATRIAL J PACING LEAD MODEL 869 (K831436) | Pacesetter Systems | 1983-06-08 |
| ULTIPORE PREBYPASS PLUS FILTER (K831286) | Pall Biomedical Products Co. | 1983-06-08 |