| PACEMAKER LEAD ADAPTOR MODEL 431 (K802407) | Pacesetter Systems | 1980-10-31 |
| MICROTHIN-PI BIPOLAR PULSE GENERATOR (K802410) | Cardiac Pacemakers, Inc. | 1980-10-31 |
| COMPUPACE, 524-01 PACER SYSTEM COMPUTER (K801055) | Intermedics, Inc. | 1980-10-31 |
| 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH (K802481) | Waters Assoc., Inc. | 1980-10-31 |
| MULTICHANNEL TELEMETRY SYSTEM (K801944) | Burdick Corp. | 1980-10-23 |
| SD-900 OSCILLOMETRIC BP MONITOR (K802218) | Industrial & Biomedical Sensors Corp. | 1980-10-23 |
| UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER (K802077) | Cardiac Pacemakers, Inc. | 1980-10-23 |
| IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC. (K801792) | Telectronics, Inc. | 1980-10-23 |
| PACEPATH MODEL 819 (K801417) | Pacesetter Systems | 1980-10-23 |
| EXTERNAL, TEMP. PORTABLE CARDIAC GENER (K801953) | Telectronics, Inc. | 1980-10-23 |
| LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM (K801455) | Pacesetter Systems | 1980-10-23 |
| MODEL 633A THREE CHANNEL STRESS TEST (K802190) | Quinton, Inc. | 1980-10-23 |
| SD-800 BLOOD PRESSURE MONITOR (K802202) | Industrial & Biomedical Sensors Corp. | 1980-10-23 |
| UNIVERSAL TEMP. PACING ELECT. #080-10000 (K801800) | Medical Testing System, Inc. | 1980-10-23 |
| TRANSVENOUS PACEMAKER ELECTRODE KIT (K802259) | Stanco Medical, Inc. | 1980-10-23 |
| SD-700 BLOOD PRESSURE MONITOR (K802201) | Industrial & Biomedical Sensors Corp. | 1980-10-23 |
| CRITERION II PACING SYSTEM MONITORS (K802325) | Dart Medical Equipment | 1980-10-23 |
| SHEATH DILATOR SET (K802327) | Stanco Medical, Inc. | 1980-10-10 |
| VASCULAR CATHETER WIREGUIDES (K802260) | Stanco Medical, Inc. | 1980-10-10 |
| TORQUE CONTROL BALLOON CATHETER (K802338) | Cordis Corp. | 1980-10-10 |
| MLC-4200 CARDIAC OUTPUT COMPUTER (K802305) | Nihon Kohden America, Inc. | 1980-10-10 |
| ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON (K802282) | Consolidated Medical Equipment, Inc. | 1980-10-10 |
| PRESSURE MONITORING LINES (K802326) | Stanco Medical, Inc. | 1980-10-10 |
| DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (K802328) | Stanco Medical, Inc. | 1980-10-10 |
| GORE-TEX VASCULAR GRAFT (K802095) | W. L. Gore & Associates, Inc. | 1980-10-10 |
| QUICK PRIME LINES, #'S BPL-12, BPL-48 & (K802378) | Bentley Laboratories, Inc. | 1980-10-10 |
| CT-1600 DIGITAL PULSE RATE MONITOR (K802204) | Industrial & Biomedical Sensors Corp. | 1980-10-03 |
| PRESSURE GAUGE ACCESSORY KIT/DILATATION (K802261) | Stanco Medical, Inc. | 1980-10-03 |
| CM-700A AUTO-INFLATE CONTROL MODULE (K802203) | Industrial & Biomedical Sensors Corp. | 1980-10-03 |
| TELEMETRY TRANSMITTER, #TLT-3 (K802273) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-10-03 |
| U.I. OCTOSON (K802030) | Ausonics Pty , Ltd. | 1980-10-03 |
| CORROSION PROOF DUAL PURPOSE ECG WIRES (K802237) | Custom Cardio Components | 1980-10-03 |
| VESSEL RETRACTOR, #600732 (K802244) | Bentley Laboratories, Inc. | 1980-10-03 |
| SORIN PULSE GENERATOR, MODEL #LIT-214 (K801640) | Bentley Laboratories, Inc. | 1980-10-03 |
| CORROSION PROOF SNAP ECG CONNECT WIRES (K802236) | Custom Cardio Components | 1980-10-03 |
| COMPUTER ECG TERMINAL (K802272) | Compumed, 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 |
| ECG RECALL & EDIT PRODUCT VERSION-A3601 (K802103) | General Electric Co. | 1980-09-26 |
| CARDIOTRAK (K802089) | Cardiac Pacemakers, Inc. | 1980-09-26 |
| IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN (K802028) | Telectronics, Inc. | 1980-09-26 |
| HEARTWATCH (K800519) | D. Jenkins | 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 |
| MEDTRONIC MODEL 69575 (K800944) | Medtronic Vascular | 1980-09-26 |
| HS10 PORTABLE OPERATING ROOM MONITOR (K802184) | Medtel Pty. , Ltd. | 1980-09-26 |
| HALL ARTERIAL OSCILLATOR (K801063) | American Sterilizer Co. | 1980-09-26 |
| BENTLEY THEROMODILUTION CATHETER #BTD-7F (K802133) | Bentley Laboratories, Inc. | 1980-09-26 |
| IMPLANTABLE PROGRAM. CARDIAC PACEMAKER (K800793) | Telectronics, Inc. | 1980-09-18 |
| SHILEY UTILITY RESERVOIR (K802119) | Shiley, Inc. | 1980-09-16 |
| DEKNATEL GOOSEN VASCULAR PUNCH BLADES (K802079) | Howmedica Corp. | 1980-09-16 |
| SIEMENS-ELEMA PULSE GENERATOR 625 (K801508) | Siemens Elema AB | 1980-09-16 |
| CYNERGY MODEL 184 (K801596) | Cynergy | 1980-09-16 |
| EVALUATOR #9500 DYNAMIC ELEC/SCANNER (K801831) | Del Mar Avionics | 1980-09-09 |
| BIO-MED CORP. DISP. NON-STERILE TRANSDU (K801985) | Bio-Med Corp. | 1980-09-09 |
| INSULATING SHEATH (K801910) | Cordis Corp. | 1980-09-09 |
| DISP. TRANSDUCER DOMES TD200 & TD300 (K802069) | Bio-Med Corp. | 1980-09-09 |
| MEDTRONIC MODEL 2409 (K800226) | Medtronic Vascular | 1980-09-09 |
| VASCULAR GRAFT PROSTH. OF EXP. MICRO. (K801621) | Impra, Inc. | 1980-09-09 |
| EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (K801806) | Arco Medical Products Co. | 1980-09-09 |
| ELECTROCARDIOGRAPH ELECTRODE (K801846) | Phoenix Glove Co. | 1980-09-09 |
| BATTERY FOR #229-01 PULSE GENERATOR (K802040) | Intermedics, Inc. | 1980-09-09 |
| PALPATION ENHANCER (K801811) | Medical Horizons Co. | 1980-09-09 |
| HANCOCK * OBTURATORS (K801885) | Hancock Laboratories, Inc. | 1980-09-09 |
| BIOMEGA #423-B BLOOD PRESSURE & PULSE CK (K801923) | Bio Mega Diagnostic, Inc. | 1980-08-27 |
| VIVALITH 5, - MDL-201A & TDL-201A (K801763) | Pacesetter Systems | 1980-08-27 |
| MICRO-PROCESSOR UNIT #A3600AC (K801762) | General Electric Co. | 1980-08-27 |
| MODEL 9200 VIS-U-SCAN (K801832) | Del Mar Avionics | 1980-08-27 |
| MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS (K801828) | Graphic Controls Corp. | 1980-08-27 |
| MEDI-TRACE DISP. FLUSHING DEV./MONITOR (K801829) | Graphic Controls Corp. | 1980-08-27 |
| MODEL 9300 ELECTROCARDIOVALIDATOR (K801830) | Del Mar Avionics | 1980-08-27 |
| SONACOLOR 6100 (K801647) | Carolina Medical Electronics | 1980-08-20 |
| MMI/GAELTEC CATHETER TIP TRANSDUC (K801756) | Medical Measurements, Inc. | 1980-08-20 |
| CORDIS FLOW DIRECTED BALLOON CATHETER (K801865) | Cordis Corp. | 1980-08-20 |
| NON-INVASIVE, BLOOD PRESSURE MONITOR (K801657) | Biochem International, Inc. | 1980-08-20 |
| PDS COMPUTER UNIT/VIDEO TERMINAL (K801761) | General Electric Co. | 1980-08-20 |
| ELECTRONIC PACEMAKER WAVEFORM ANALYZER (K800696) | Instromedix, Inc. | 1980-08-14 |
| INTERMEDICS THIN LITH IV SERIES UNIPOLAR (K801450) | Intermedics, Inc. | 1980-08-14 |
| IONESCU-SHILEY PERICARDIAL PATCH (K801764) | Shiley, Inc. | 1980-08-13 |
| UNI-RECORD I (K801700) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-08-07 |
| ELECTROCARDIOGRAPH, MODEL ECG-5503 (K801677) | Nihon Kohden America, Inc. | 1980-08-07 |
| ARTERIAL BUBBLE TRAP (K801770) | Delta Medical Industries | 1980-08-07 |
| DESERET EMBOLECTOMY/THROMBECTOMY CATH. (K801650) | Deseret Medical, Inc. | 1980-08-04 |
| SHIELD DISPOSABLE BLOOD PRESSURE CUFF (K801568) | American Convertors Div., American Pharmaseal | 1980-07-28 |
| PRUITT VASCULAR SHUNT (K801359) | Ideas For Medicine, Inc. | 1980-07-28 |
| BARO/TRAC II & VITA/TRAC, VITAL SIGN MON (K801389) | Bib, Inc. | 1980-07-28 |
| BLADE SEPTOSTOMY CATHETER (K801031) | Cook, Inc. | 1980-07-28 |
| DILATOR, VESSEL, FOR PERC. CATHETER. (K801113) | Alva Medical, Inc. | 1980-07-28 |
| OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT (K801641) | Ohio Medical Products | 1980-07-28 |
| MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR (K801552) | Edwards Laboratories | 1980-07-28 |
| SINVISION LINEAR ARRAY REAL TIME (K800653) | Kt Medical, Inc. | 1980-07-21 |
| LINEAR ARRAY SCANNER (K800805) | Philips Medical Systems (Cleveland), Inc. | 1980-07-21 |
| ADAPTAID HELICAL COIL ADAPTER 365-14 (K801039) | Intermedics, Inc. | 1980-07-21 |
| A-V MINI CLINIC (K800405) | Instromedix, Inc. | 1980-07-21 |
| VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR (K800596) | Bib, Inc. | 1980-07-21 |
| ULTRA IMAGER (K800553) | Honeywell, Inc. | 1980-07-21 |
| HIGH STOY SMALL PARTS SCANNER #SP-100B (K800850) | Highstoy | 1980-07-21 |
| MODEL R11 SINGLE CHANNEL CHART RECORDER (K801549) | Medasonics, Inc. | 1980-07-14 |
| CARDIOTOMY RESERVOIR WITH FILTER (K801360) | Travenol Laboratories, S.A. | 1980-07-14 |