| SORENSON THERMODILUTION CARDIAC COMPUT (K812757) | Sorensen Research | 1981-11-02 |
| SHILEY ARTERIAL FILTER W/40 MICRON SCREE (K812742) | Shiley, Inc. | 1981-11-02 |
| NARCO TELECARE PRESSURE TRANSDUCER DOME (K812884) | Narco Scientific | 1981-11-02 |
| SPHYGMOMANOMETER (K812409) | Somatronix Research Corp. | 1981-11-02 |
| FLOW-DIRECTED BALLOON THERMODILUTION (K812761) | Nova Medical Specialties | 1981-11-02 |
| MODEL 325T PROGRAMMABLE PULSE GENERATOR (K812358) | Cook Pacemaker Corp. | 1981-10-29 |
| IMPLANTABLE VENTRICULAR-INHIBITED CARDI (K812790) | Telectronics, Inc. | 1981-10-29 |
| ADAPTAID #365-38 (K812756) | Intermedics, Inc. | 1981-10-29 |
| MODEL 841 ENDOCARDIAL TINED LEAD (K812816) | Pacesetter Systems | 1981-10-29 |
| MODEL 833 ENDOCARDIAL TINED LEAD (K812815) | Pacesetter Systems | 1981-10-29 |
| TEMPORARY PERVENOUS J-ATRIAL LEAD (K812781) | Cordis Corp. | 1981-10-29 |
| INTERMEDICS PROGRAMMER, MODEL 522-03 (K812813) | Intermedics, Inc. | 1981-10-27 |
| INTERMEDICS ADAPTAID STEP-DOWN ADAPTER (K812812) | Intermedics, Inc. | 1981-10-27 |
| MEDTRONIC #4951 (K812599) | Medtronic Vascular | 1981-10-23 |
| SUCKER CARDIOTOMY RETURN, C.P. BYPASS (K812455) | Electromedics, Inc. | 1981-10-23 |
| MODEL 9408 A TELETRACE (K812703) | Medtronic Vascular | 1981-10-23 |
| ZEE LIFE SUPPORT AIR PANTS (K812564) | Zee Medical Products Co., Inc. | 1981-10-23 |
| LYMPHA PRESS (K810338) | Mego Afek | 1981-10-20 |
| PHYSIOLOGICAL PRESSURE TRANSDUCER (K812758) | Electromedics, Inc. | 1981-10-20 |
| FLOW-DIRECTED THERMODILUTION CATHETER (K812800) | Sorensen Research | 1981-10-20 |
| ECG MEDATAPE-601 (K812763) | Hospital Equipment Service | 1981-10-20 |
| ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J (K811593) | Telectronics, Inc. | 1981-10-13 |
| AMPLITONE-3 (K812676) | Progressive Technology, Inc. | 1981-10-13 |
| IMPLANTAID LEAD INTRODUCER #319-10 & 12 (K812502) | Intermedics, Inc. | 1981-10-13 |
| CARDIAC PACING ELECTRODES (K812517) | Medics Instrument Corp. | 1981-10-13 |
| PRE-BYPASS FILTER (K812539) | Gelman Sciences, Inc. | 1981-10-13 |
| KALOS-03 (K812218) | Biotronik Sales, Inc. | 1981-10-13 |
| TRANSDUCER DOME (K812530) | Biomeal Corp. | 1981-10-13 |
| DORROS-SPRING PRESSURIZER (K812304) | Cardiovascular Diagnostic Services | 1981-10-13 |
| INFANT CARIDAC MONITOR (K812674) | Electromed Intl., Ltd. | 1981-10-13 |
| INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL (K812245) | Intermedics, Inc. | 1981-10-06 |
| INTERMEDICS POLY FLEX EPICARDIAL SUTURE (K812221) | Intermedics, Inc. | 1981-10-06 |
| UNICUFF (K812639) | Frontier Products | 1981-10-02 |
| VASCULAB #R12B (K812608) | Medasonics, Inc. | 1981-10-02 |
| URE SIL EMBOLECTOMY/THROMBECTOMY CATH (K812640) | Uresil Corp. | 1981-10-02 |
| VASCULAB #VSC21 (K812609) | Medasonics, Inc. | 1981-10-02 |
| CARDIAC REVIEW STATION (K812515) | Diasonics, Inc. | 1981-10-02 |
| CENTERAL MONITOR 360 (K812144) | Life Science Instrumentation, Inc. | 1981-09-25 |
| CARDIORATER CR-3 (K812145) | Life Science Instrumentation, Inc. | 1981-09-25 |
| CARDIORATER CR-7 (K812147) | Life Science Instrumentation, Inc. | 1981-09-25 |
| SWAN-GANZ & EDSLAB HEPARIN COATED CATH. (K812563) | American Edwards Laboratories | 1981-09-25 |
| FLOW-DIRECTED THERMODILUTION CATHETER (K812324) | Sorensen Research | 1981-09-25 |
| DISPOSABLE ELECTRODE, #1610 (K812276) | Andover Medical, Inc. | 1981-09-25 |
| KONTRON PMS 7000 (K812354) | Kontron Instruments, Inc. | 1981-09-25 |
| 2000 SERIES PORTABLE RESUSCITATION SYST. (K812519) | Life Science Instrumentation, Inc. | 1981-09-25 |
| CARDIORATER CR-5 (K812146) | Life Science Instrumentation, Inc. | 1981-09-25 |
| 280/4 MINI-DEFIBRILLATOR (K812520) | Life Science Instrumentation, Inc. | 1981-09-25 |
| MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY (K811464) | Intermedics, Inc. | 1981-09-23 |
| TELEMETRY DECODER (K801339) | Intermedics, Inc. | 1981-09-23 |
| CYBERLITH IX IMPLANTABLE PULSE GENERATOR (K801337) | Intermedics, Inc. | 1981-09-23 |
| MEDTRONIC MODEL 2409 (K812580) | Medtronic Vascular | 1981-09-23 |
| NIVP MONITOR (K812259) | Datascope Corp. | 1981-09-21 |
| USCI TRANSTHORACIC TEMP. PACING ELECTROD (K812307) | C.R. Bard, Inc. | 1981-09-21 |
| PORTAPULSE (K812131) | Gavon, Inc. | 1981-09-21 |
| INTK-08 8 FRENCH INTRODUCER KIT W/SIDE (K812325) | Sorensen Research | 1981-09-21 |
| DEFIBRILLATOR/MONITOR (K812317) | Hewlett-Packard Co. | 1981-09-21 |
| PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL (K812270) | Diag Corp. | 1981-09-16 |
| CARDIACMONITORS (K811425) | Pulse Time Products, Ltd. | 1981-09-16 |
| MEDTRONIC ENERTRAX MODEL 7100 (K812096) | Medtronic Vascular | 1981-09-16 |
| MANUFACTURING PROCESS CHANGE (K811441) | Meadox Medicals, Div. Boston Scientific Corp. | 1981-09-16 |
| GORE-TEX CARDIOVASCULAR PATCH (K811841) | W. L. Gore & Associates, Inc. | 1981-09-16 |
| ANGIOSCAN SPECTRUM ANALYZER (K812184) | Unigon Industries, Inc. | 1981-09-09 |
| NOVAMETRIX PHYSIOLOGICAL MONITOR #910 (K811893) | Novametrix Medical Systems, Inc. | 1981-09-08 |
| MEDTRONIC SPECTRAX (K812153) | Medtronic Vascular | 1981-08-31 |
| NEOLOOPS (K810890) | Medical Marketing Systems | 1981-08-31 |
| DACRON PLEDGET SUTURE BUTTRESS (K812254) | ETHICON, Inc. | 1981-08-31 |
| CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. (K812168) | Cordis Corp. | 1981-08-31 |
| CENTRAL STATION MONITOR (K812271) | Datascope Corp. | 1981-08-31 |
| BO MED BIA (K811999) | Bomed Medical Mfr., Ltd. | 1981-08-31 |
| CARDIO-DATA SYSTEM, #MARK III (K812149) | Cardio Data | 1981-08-31 |
| INTERFACE PRE BYPASS PRIME FILTER #90 (K812244) | Medical, Inc. | 1981-08-25 |
| INTERFACE PRE BYPASS PRIME FILTER (K812240) | Medical, Inc. | 1981-08-25 |
| ELECTRONIC STETHOSCOPE #S-50 (K812148) | Syphgmostat | 1981-08-25 |
| INTERFACE CARDIOTOMY BLOOD FILTER #51 (K812243) | Medical, Inc. | 1981-08-25 |
| GORE-TEX VASULAR GRAFT (K811510) | W. L. Gore & Associates, Inc. | 1981-08-20 |
| FLUSHFLO II (K812173) | Bentley Laboratories, Inc. | 1981-08-18 |
| INTRODUCER, PERCUTANEOUS (K812143) | Willson | 1981-08-18 |
| PACEPATH IMPLANTABLE ENDOCARD. PACING LD (K811200) | Pacesetter Systems | 1981-08-13 |
| SPACELABS' SYSTEM AUTORECORDER (K811540) | Spacelabs, Inc. | 1981-08-13 |
| COBE HEAT EXCHANGER RESERVOIR MODULE (K812093) | Cobe Laboratories, Inc. | 1981-08-13 |
| BACH-SIMPSON MODEL BVM30 (K811615) | Bach-Simpson , Ltd. | 1981-08-13 |
| ULTRASONIC QFM SYSTEM 1000 (K811376) | Narco Bio-Systems | 1981-08-13 |
| CORDIS DUCOR PTR SYSTEM (K811971) | Cordis Corp. | 1981-08-13 |
| KENL-ECG-3 (K811949) | Suzuken Co., Ltd. | 1981-08-13 |
| HEMOTHERM MODEL 400 (K811742) | Cincinnati Sub-Zero | 1981-08-13 |
| SPHGOMOMANOMETER (K812059) | Med-Tek Corp. | 1981-08-13 |
| KENL-ECG (K811950) | Suzuken Co., Ltd. | 1981-08-13 |
| BACH-SIMPSON MODEL TS266 (K811616) | Bach-Simpson , Ltd. | 1981-08-13 |
| ADAPTAID LEAD ADAPTER, #365-17 (K811920) | Intermedics, Inc. | 1981-08-13 |
| ARRHYTHMIA FUNCTION BLOCK (K811581) | Honeywell, Inc. | 1981-08-13 |
| USCI DOPPLER CATHETER SYSTEM (K810414) | C.R. Bard, Inc. | 1981-08-12 |
| SP-100-B SMALL PARTS SCANNER SYSTEM (K811595) | Highstoy | 1981-08-12 |
| TEFLON PLEDGET SUTURE BUTTRESS (K811872) | ETHICON, Inc. | 1981-08-12 |
| DOPPLER ULTRASOUND BLOOD FLOWMETER (K811246) | Irex Corp. | 1981-08-12 |
| TYPE FH ENDOCARDIAL LEAD (K810494) | Biotronik Sales, Inc. | 1981-08-07 |
| ADAPTAID LEAD ADAPTER #365-25 (K811938) | Intermedics, Inc. | 1981-08-07 |
| ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR (K811758) | Powers Medical Systmes | 1981-08-03 |
| MODEL 84 TRANSPORT SYSTEM (K811372) | Datascope Corp. | 1981-08-03 |
| MODEL A UNIPOLAR ENDOCARDIAL LEAD (K811879) | Cook Pacemaker Corp. | 1981-08-03 |
| MODEL C UNIPOLAR ENDOCARDIAL LEAD (K811877) | Cook Pacemaker Corp. | 1981-08-03 |