| CARDIOBEEPER CB250 (K983582) | Merdian Medical Technologies , Ltd. | 1998-11-13 |
| CV PERI-GUARD AND VASCU-GUARD (K983602) | Bio-Vascular, Inc. | 1998-11-12 |
| STRATEGY CORONARY WIRE GUIDE (K983771) | Cook, Inc. | 1998-11-12 |
| SCIMED INFORMER PRESSURE WIRE SYSTEM (K974241) | Scimed Life Systems, Inc. | 1998-11-12 |
| CMS-2000 (K982843) | Industrial Technology Research Institute | 1998-11-10 |
| HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 (K982876) | Guidant Corp. | 1998-11-10 |
| DIGITAL ECG HOLTER RECORDER, MODEL DR512 (K982975) | Datrix | 1998-11-10 |
| ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE (K983033) | Guidant Corp. | 1998-11-10 |
| SIEMENS SC 8000 BEDSIDE MONITOR (K983632) | Siemens Medical Solutions USA, Inc. | 1998-11-06 |
| DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS (K983684) | Datex-Ohmeda, Inc. | 1998-11-06 |
| MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (K983287) | Graphic Controls Corp. | 1998-11-05 |
| BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) (K971616) | Data Sciences Intl., Inc. | 1998-11-04 |
| DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 (K981378) | Datex-Engstrom, Inc. | 1998-11-03 |
| 9303 NEONATAL/ADULT VITAL SIGNS MONITOR (K982776) | Cas Medical Systems, Inc. | 1998-11-02 |
| ELECTRODE SWITCHBOX, MODEL 11-081002 (K982835) | Cardima, Inc. | 1998-10-29 |
| MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT (K974581) | Invivo Research, Inc. | 1998-10-28 |
| SHELHIGH NO-REACT VASCUPATCH (K982810) | Shelhigh, Inc. | 1998-10-28 |
| PIOLAX HYDROPHILIC GUIDEWIRE (K980977) | Piolax Medical Devices, Inc. | 1998-10-27 |
| COBE SMARXT TUBING AND CONNECTORS (K981613) | Cobe Cardiovascular, Inc. | 1998-10-26 |
| MODEL 2000 PULSE OXIMETER (K982255) | Ivy Biomedical Systems, Inc. | 1998-10-22 |
| DOCKING-EXTENSION WIRE (K982592) | Schneider (Europe) GmbH | 1998-10-21 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 (K982896) | Alexander Mfg. Co. | 1998-10-21 |
| SPYGLASS 5 FR ANGIOGRAPHIC CATHETER (K982299) | Daig Corp. | 1998-10-19 |
| Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters (K981660) | C.R. Bard, Inc. | 1998-10-16 |
| ENVY GUIDING CATHETER (K974774) | Cook, Inc. | 1998-10-16 |
| MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (K982220) | Medtronic Vascular | 1998-10-15 |
| CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K981697) | Cambridge Heart, Inc. | 1998-10-14 |
| ECG ELECTRODES APRON (K982470) | Tapuz Medical Technology , Ltd. | 1998-10-14 |
| CARDIOPAL MODEL NUMBER PM20 (K981119) | Medicomp, Inc. | 1998-10-14 |
| BARD HYDROPHILLIC COATED GUIDE WIRE (K974713) | C.R. Bard, Inc. | 1998-10-14 |
| VGF-7 VASCULAR GRAFT FLOWMETER (K973198) | Medicard , Ltd. | 1998-10-14 |
| MEDRAD VISTRON CT INJECTOR SYSTEM (K982814) | Medrad, Inc. | 1998-10-09 |
| COBE VACUUM RELIEF CHECK VALVE (K982406) | Cobe Cardiovascular, Inc. | 1998-10-07 |
| ZYMED TELEMETRY SYSTEM (K980186) | Agilent Technologies | 1998-10-07 |
| SPO2 FINGER PROBES (K973970) | Medical Cables, Inc. | 1998-10-06 |
| MAGNATEK 40 (K982907) | Magna Advanced Technologies, Inc. | 1998-10-02 |
| BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP (K982538) | Belmont Instrument Corp. | 1998-10-02 |
| MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K983023) | Cordis Corp. | 1998-10-01 |
| CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS (K982891) | California Medical Laboratories, Inc. | 1998-09-30 |
| BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 (K981394) | Braemar Corp. | 1998-09-28 |
| A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR (K982481) | A&D Engineering, Inc. | 1998-09-25 |
| PRESS-MATE ADVANTAGE (K973637) | Colin Medical Instruments Corp. | 1998-09-25 |
| VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (K982279) | Bci Intl., Inc. | 1998-09-25 |
| EWC: ECG CABLE AND LEADWIRE SYSTEMS (K982817) | Ewc | 1998-09-23 |
| FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 (K982182) | Radi Medical Systems AB | 1998-09-18 |
| 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS (K983003) | Cordis Neurovascular, Inc. | 1998-09-17 |
| MTEK-1000 (K982405) | Magna Advanced Technologies, Inc. | 1998-09-17 |
| FAST-CATH INTRA-CARDIAC INTRODUCER (K982187) | Daig Corp. | 1998-09-16 |
| OSCILLOMATE EMS NIBP MONITOR MODEL 9001 (K982135) | Cas Medical Systems, Inc. | 1998-09-15 |
| ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K982083) | Guidant Corp. | 1998-09-11 |
| KELLER PULSE OXIMETER, MODEL 850+ (K982331) | Keller Medical Specialties Products, Inc. | 1998-09-11 |
| INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) (K980578) | Innerdyne, Inc. | 1998-09-11 |
| COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD (K982254) | Cobe Cardiovascular, Inc. | 1998-09-10 |
| CAPIOX SX HARDSHELL RESEVOIR (K982223) | Terumo Medical Corp. | 1998-09-10 |
| SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 (K980869) | Biotronik, Inc. | 1998-09-10 |
| HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) (K980429) | Hewlett-Packard Co. | 1998-09-09 |
| MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER (K982883) | Medtronics Interventional Vascular | 1998-09-04 |
| STOCKERT COMPACT SYSTEM (K982014) | Stoeckert Instrumente | 1998-09-04 |
| HEARTPORT ENDOPULMONARY VENT CATHETER (K981009) | Heartport, Inc. | 1998-09-04 |
| BIOSENSORS EMBOLECTOMY CATHETER (K973477) | Sunscope Intl., Inc. | 1998-09-04 |
| HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR (K982025) | Hewlett-Packard Co. | 1998-09-04 |
| PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE (K980762) | Pall Corp. | 1998-09-01 |
| ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 (K982141) | Arrow Intl., Inc. | 1998-08-31 |
| CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S (K982740) | Cordis Webster, Inc. | 1998-08-28 |
| CAOW HEMOSTASIS SYSTEM (K972689) | Anlam Corp. | 1998-08-27 |
| EC6 PLETHYSMOGRAPH (K982707) | D. E. Hokanson, Inc. | 1998-08-26 |
| MT-200 (K973751) | Schiller America, Inc. | 1998-08-25 |
| MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K974220) | Micromedical, Inc. | 1998-08-25 |
| MICROVIT MT-100 (K973735) | Schiller America, Inc. | 1998-08-25 |
| SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR (K982730) | Siemens Medical Solutions USA, Inc. | 1998-08-24 |
| COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 (K980786) | Cobe Cardiovascular, Inc. | 1998-08-24 |
| AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (K981939) | Bci Intl., Inc. | 1998-08-20 |
| SABRATEK PATIENT HOME MANAGEMENT SYSTEM (K980619) | Sabratek Corp. | 1998-08-20 |
| PTA BALLOON CATHETER (K980390) | Cook, Inc. | 1998-08-20 |
| BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX (K981747) | Sunscope Intl., Inc. | 1998-08-20 |
| NPB3900 SERIES PATIENT MONITORS (K980411) | Analogic Corp. | 1998-08-20 |
| CARDIOVISION SOFTWARE, MODEL S-CV5-96 (K981807) | Shl Telemedicine International , Ltd. | 1998-08-19 |
| FUTREX-6100/XL (K963271) | Futrex, Inc. | 1998-08-19 |
| 6F ENVOY GUIDING CATHETER (K982770) | Cordis Corp. | 1998-08-18 |
| SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER (K981788) | Scimed Life Systems, Inc. | 1998-08-18 |
| ENVOY AND VISTA BRITE TIP (K982632) | Cordis Corp. | 1998-08-18 |
| DINAMAP MPS SELECT PORTABLE MONITOR (K982342) | Critikon Company, LLC | 1998-08-14 |
| MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR (K982697) | Mennen Medical, Inc. | 1998-08-12 |
| ANS 2000 ECG MONITOR AND RESPIRATION PACER (K973426) | D. E. Hokanson, Inc. | 1998-08-12 |
| D903 AVANT ADULT HOLLOW FIBER OXYGENATOR (K980600) | Dideco S.P.A. | 1998-08-12 |
| BETTER-BLADDER (BB) (K981284) | Circulatory Technology, Inc. | 1998-08-12 |
| LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM (K981782) | Arrow Intl., Inc. | 1998-08-12 |
| SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K980453) | Boston Scientific Scimed, Inc. | 1998-08-11 |
| SELECTOR DIAGNOSTIC CATHETER (K982077) | Boston Scientific Scimed, Inc. | 1998-08-11 |
| CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 (K982415) | Cordis Webster, Inc. | 1998-08-10 |
| AECD ARRHYTHMIA DETECTION SOFTWARE (K982710) | Cardiac Science, Inc. | 1998-08-10 |
| EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET (K980504) | Schneider/Namic | 1998-08-07 |
| MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (K980016) | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 |
| CONTOR TABLE SURFACE (K973705) | Hill-Rom, Inc. | 1998-08-07 |
| MEDTRONIC ZUMA GUIDING CATHETER (K981198) | Medtronics Interventional Vascular | 1998-08-07 |
| STABLEMAPR STEERABLE INTRACARDIAC CATHETERS (K981642) | Medtronic Cardiorhythm | 1998-08-05 |
| BARD QUANTUM SVR MODEL NUMBER H-6440VR (K981628) | C.R. Bard, Inc. | 1998-08-05 |
| BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 (K971892) | Biomedical Horizons, Inc. | 1998-08-05 |
| CT 200 ELECTROCARDIOGRAPH (K961798) | Macquarie Medical Systems | 1998-08-05 |
| SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (K974648) | Sulzer Carbomedics, Inc. | 1998-08-04 |