| PRESSURE MONITOR (K842194) | Norton Texas Medical Products | 1984-08-27 |
| CARDIOTOMY RESERVOIR W/FILTER BCR-3500 (K842620) | American Bentley | 1984-08-27 |
| ANGIOGRAPHIC PROCEDURE TRAY (K840391) | Triad Medical Division | 1984-08-27 |
| ELECTRONIC DIGITAL BP METER HC 3001 (K842486) | North American Philips Corp. | 1984-08-24 |
| BP-1000 (K843009) | Pollenex Associated Mills, Inc. | 1984-08-24 |
| BP800, 850 1000 (K841095) | Associated Mills, Inc. | 1984-08-24 |
| CPR LOCATOR (K833737) | Lifepoint,Inc | 1984-08-24 |
| TX-2 THERMAL DILUTION CARDIAC OUTPUT (K834408) | Waters Instruments, Inc. | 1984-08-23 |
| TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO (K843262) | Hewlett-Packard Co. | 1984-08-23 |
| DYNASCOPE SERIES (K840055) | Fukuda Denshi USA, Inc. | 1984-08-22 |
| NOVA 12 CARDIAC OUTPUT COMPUTER (K840009) | Nova Medical Specialties | 1984-08-22 |
| FINE NEEDLE ASPIRATION DEVICE (K841275) | Gyneco, Inc. | 1984-08-17 |
| SHILEY VENOUS RESERVOIR (K842337) | Shiley, Inc. | 1984-08-17 |
| NOVA BALLOON THERMODILUTION CATH. (K841639) | Nova Medical Specialties | 1984-08-12 |
| FLUSH DEVICE (K833170) | Transamerica Delaval, Inc. | 1984-08-12 |
| NOVA BALLOON THERMODILUTION INFUSION (K841640) | Nova Medical Specialties | 1984-08-12 |
| COMPUTER, CENTRAL PROCESSING UNIT (K841261) | Nem Computer Corp. | 1984-08-10 |
| SHILEY CARDIOTOMY RESERVOIR W/FILTER (K842711) | Shiley, Inc. | 1984-08-10 |
| SARNS EVACUPLEGE CATHETER (K842044) | 3M Health Care, Sarns | 1984-08-10 |
| PERIPHERAL DILATATION ANGIOPLASTY-CATH (K834429) | American Edwards Laboratories | 1984-08-10 |
| ADVANCED CARDIOVASCULAR BALLOON DILATA (K842556) | Advanced Cardiovascular Systems, Inc. | 1984-08-10 |
| PERCUTANEOUS ANGIOSCOPE DELIVERY CATH (K842799) | American Edwards Laboratories | 1984-08-10 |
| INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH (K842798) | American Edwards Laboratories | 1984-08-10 |
| GAMBRO PULSATILE MONITOR PLM 10-200 (K842503) | Gambro, Inc. | 1984-08-10 |
| VENOUS CANNULA W/BENT, TIP WIRE (K842375) | Dlp, Inc. | 1984-08-10 |
| MULTIPRO CATHETER (K841797) | Shiley, Inc. | 1984-08-10 |
| NEOS LP (K841633) | Biotronik Sales, Inc. | 1984-08-06 |
| DESERET DISPOSABLE PRESSURE TRANSDUCER (K841968) | Parke-Davis Co. | 1984-08-06 |
| SCANLAN ENDARSECTOR (K841521) | Scanlan Intl., Inc. | 1984-08-03 |
| PALL EC PLUS FILTER W/FILTER SLEEVE (K834382) | Pall Biomedical Products Co. | 1984-08-03 |
| SOLUTION CLARIFICATION UNIT (K842141) | Pall Biomedical Products Co. | 1984-08-03 |
| AIR SHIELDS AS461 MONITORING SYS (K842321) | Air-Shields, Inc. | 1984-08-03 |
| TUBULAR HOLLOW FIBER MEMBRANE (K841476) | American Bentley | 1984-08-03 |
| COBE EMERGENCY POWER SOURCE 43610-000 (K842138) | Cobe Laboratories, Inc. | 1984-08-03 |
| PALL EC PLUS FILTER (K834380) | Pall Biomedical Products Co. | 1984-08-03 |
| LITHIUM PACEMAKER 811-811L & 811XL (K840748) | Omikron Scientific, Ltd. | 1984-08-03 |
| ARTERIAL EMBOLECTOMY CATHETER (K840198) | Shiley, Inc. | 1984-08-03 |
| MEDTRONIC 6210 PERMANENT LEAD INTRODUC (K842780) | Medtronic Vascular | 1984-08-03 |
| MODEL 866 PERMATHANE BIPOLAR, COAXIAL (K841739) | Pacesetter Systems | 1984-08-03 |
| MODEL 110-5 & 140-8 (K842005) | Camino Laboratories, Inc. | 1984-08-03 |
| LEPTOS (K841635) | Biotronik Sales, Inc. | 1984-08-03 |
| ELECTROCARDIOGRAPH E-340 (K840440) | Burdick Corp. | 1984-08-03 |
| CENTRIMED SYSTEM 1 (K842007) | Centrimed Corp. | 1984-08-03 |
| FASTPASS IMPLANTABLE ENDOCARDIAL PAC (K841885) | Pacesetter Systems | 1984-08-03 |
| CARDIOPLEGIA RESERVOIR CAS-2000 (K841938) | American Bentley | 1984-08-03 |
| QUINTON 901 & 900 HOLTER SCANNER (K841611) | Quinton, Inc. | 1984-08-02 |
| COBE AEPS (K842054) | Cobe Laboratories, Inc. | 1984-08-02 |
| PCI W/CATH-SEAL SIDE FLOW FITTING (K842259) | Universal Medical Instrument Corp. | 1984-08-01 |
| AXIOM FEMORAL VENUS CATHETER (K842084) | Axiom Medical, Inc. | 1984-08-01 |
| MONITOR ONE (K841172) | Qmed, Inc. | 1984-07-27 |
| KEYMED SIGMOIDOSCOPE SUCTION UNIT (K841822) | Keymed, Inc. | 1984-07-27 |
| CRITIKON TRIPLE-LUMEN CENTRAL VENOUS (K842316) | Critikon Company, LLC | 1984-07-20 |
| MINI-DOPPLER ES-100 (K840542) | Hayashi Denki Co., Ltd. | 1984-07-16 |
| AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT (K842113) | Mallinckrodt Critical Care | 1984-07-13 |
| ADVANCED CARDIOVASCULAR-CORONARY GUID (K842195) | Advanced Cardiovascular Systems, Inc. | 1984-07-13 |
| POLYURETHANE THERMAL DILUTION CATHET (K841876) | Waters Instruments, Inc. | 1984-07-13 |
| CENTRAL VENOUS CATHETER W/BIG-GARD (K841828) | Norton Performance Plastics Corp. | 1984-07-13 |
| PERCUTANEOUS CATHETER INTRODUCER SET (K842004) | Aries Medical, Inc. | 1984-07-13 |
| WEDGE PRESSURE CATHETER FLOW DIRECTED (K841705) | Mansfield Scientific, Inc. | 1984-07-13 |
| SILVERTORQUE CEREBRAL CATHETER (K840762) | Surgimed Corp. | 1984-07-13 |
| RAAF DUAL LUMEN CATHETER (K842176) | Quinton, Inc. | 1984-07-13 |
| COOK PACEMAKER 216 BIPOLAR CARDIAC - (K841983) | Cook Pacemaker Corp. | 1984-07-11 |
| COOK PACEMAKER 215 UNIPOLAR CARDIAC- (K841928) | Cook Pacemaker Corp. | 1984-07-11 |
| COOK PACEMAKER CORP. 115 UNIPOLAR CARDI (K842081) | Cook Pacemaker Corp. | 1984-07-06 |
| MULTIVARIATE DIGITAL CARDIOGRAPH (K840875) | Clinical Microsystems Intl. | 1984-07-06 |
| BP TRAUMA AIR PANTS (K841605) | Bp Medical Systems, Inc. | 1984-07-06 |
| PULSE GENERATOR 678L (K841233) | Siemens Elema AB | 1984-07-06 |
| ACS SOF-T GUIDE WIREE (K840795) | Advanced Cardiovascular Systems, Inc. | 1984-07-02 |
| 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK (K841995) | Quinton, Inc. | 1984-07-02 |
| CARDIO EXPRESS 100 HOLTER SCANNER (K840622) | Del Mar Avionics | 1984-07-02 |
| PULSE GENERATOR 688B & 688L (K841231) | Siemens Elema AB | 1984-06-26 |
| PULSE GENERATOR 718B & 718L (K841228) | Siemens Elema AB | 1984-06-26 |
| PULSE GENERATOR 728, 728B & 728L (K841226) | Siemens Elema AB | 1984-06-26 |
| PULSE GENERATOR 698, 698B & 698L (K841229) | Siemens Elema AB | 1984-06-25 |
| PULSE GENERATOR KALOS-04 (K841950) | Biotronik Sales, Inc. | 1984-06-25 |
| NEOS M (K841636) | Biotronik Sales, Inc. | 1984-06-25 |
| TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC (K840023) | American Bentley | 1984-06-22 |
| Q-MED ELECTRODE (K840465) | Qmed, Inc. | 1984-06-19 |
| AUTOMATED NON-INVASIVE PRESSURE MODULE (K840909) | Gould, Inc. | 1984-06-15 |
| DIGITAL SPHYGMOMANOMETER UA-273 (K841381) | Promedical Industries, Inc. | 1984-06-14 |
| DIGITAL SPHYGMOMANOMETER UA-254 (K841380) | Promedical Industries, Inc. | 1984-06-14 |
| CENTRAL VENOUS ACCESS CATHETER CVAC-XX (K841587) | Gish Biomedical, Inc. | 1984-06-13 |
| SILVERTORQUE CARDIAC CATHETERS (K840763) | Surgimed Corp. | 1984-06-13 |
| HOLDER FOR BOS-10, 10S 5S (K841812) | American Bentley | 1984-06-11 |
| CARDIOSEARCH RIGHT ATRIAL CATH- (K833873) | Cardio Search, Inc. | 1984-06-11 |
| DESERET HEPARIN COATED FLOW DIRECTED (K841317) | Parke-Davis Co. | 1984-06-11 |
| MODEL 1000 APC-ANGIOPLASTY PRESSURE (K841493) | E.A. Fischione Instrument Mfg. | 1984-06-11 |
| PORTA PAK 90 (K840900) | Medical Research Laboratories, Inc. | 1984-06-11 |
| DESERET HEPARIN COATED FLOW CATH (K841251) | Parke-Davis Co. | 1984-06-11 |
| TUBE TENDER (K841296) | The Anspach Effort, Inc. | 1984-06-11 |
| PRESSURE CATHETER PLACEMENT SET 50010 (K841482) | Dlp, Inc. | 1984-06-11 |
| SILVERTORQUE VISCERAL CATHETER (K840761) | Surgimed Corp. | 1984-06-11 |
| TEMPERATURE CONTROL & MONITOR (K841402) | Sams, Inc. | 1984-06-11 |
| PMA ANGIOGRAPHY TRAY (K841468) | Professional Medical Services | 1984-06-05 |
| TIMEX HEALTHCHECK DIGITAL BP MONITOR (K841616) | Timex Medical Products Corp. | 1984-06-05 |
| LEAP FROG (K834211) | Philips Medical Systems (Cleveland), Inc. | 1984-06-05 |
| ELECATH HEPARIN-COATED CATHETERS (K841615) | Electro-Catheter Corp. | 1984-06-05 |
| SERVOMED BASIC BEDSIDE UNIT SMA 102- (K832250) | Litton Medical Electronics | 1984-06-01 |
| EXTENSION BOX EB200 (K834530) | Honeywell, Inc. | 1984-06-01 |
| I-CHANNEL RECORDER (K833000) | Litton Medical Electronics | 1984-06-01 |