| AFFINITY MEDICAL PATIENT CABLE SYSTEM (K980806) | Affinity Medical Technologies, LLC | 1998-03-25 |
| BCI 3401 HANDHELD PULSE OXIMETER (K980714) | Bci Intl., Inc. | 1998-03-25 |
| MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) (K971910) | Hewlett-Packard GmbH | 1998-03-23 |
| ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE (K980119) | Guidant Corp. | 1998-03-20 |
| A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR (K980824) | A&D Engineering, Inc. | 1998-03-19 |
| M1765A ECG MANAGER (K974746) | Hewlett-Packard Co. | 1998-03-18 |
| BIOZ.COM SYSTEM (K974725) | Cardiodynamics International Corp. | 1998-03-18 |
| DCAT EMBOLECTOMY CATHETER SYSTEM (K971314) | AngioDynamics, Inc. | 1998-03-17 |
| ZOLL REVIVER (K972241) | Zoll Medical Corp | 1998-03-16 |
| MULTI-LINK CABLE AND LEAD WIRE SYSTEMS (K980582) | Marquette Medical Systems, Inc. | 1998-03-16 |
| HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC (K974773) | Guidant Corp. | 1998-03-13 |
| COAXIAL DILATOR SET (K974640) | Boston Scientific Corp | 1998-03-13 |
| WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS (K973474) | Witt Biomedical Corporation | 1998-03-13 |
| CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) (K973061) | Citizen Watch Co., Ltd. | 1998-03-13 |
| MS-700 (K972213) | Alan S. Lee | 1998-03-13 |
| TS2000 MEDICAL DEVICE MONITOR (K973640) | Trincore Systems, Inc. | 1998-03-12 |
| REUSABLE FINGER SENSOR 3444 (K974697) | Bci Intl., Inc. | 1998-03-11 |
| ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B (K972603) | Dr. Lee Co., Ltd. | 1998-03-11 |
| TEMPORARY OCCLUSION BALLOON SYSTEM (K972777) | Percu Surge, Inc. | 1998-03-11 |
| AMPLATZ GOOSE NECK SNARE KIT/ CATHETER (K972511) | Microvena Corp. | 1998-03-06 |
| TIR/TIJ AND POLYROX (K972500) | Biotronik, Inc. | 1998-03-04 |
| BIOSENSOR HOLTER MONITOR SYSTEM (K974192) | Biosensor Corp. | 1998-03-04 |
| OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM (K971840) | Invivo Research, Inc. | 1998-03-04 |
| BIOSENSOR HOLTER MONITOR SYSTEM (K974546) | Biosensor Corp. | 1998-03-04 |
| PORTABLE INTENSIVE CARE UNIT (K974034) | Medical Research Laboratories, Inc. | 1998-03-02 |
| S3 MAST PUMP (K972321) | Stoeckert Instrumente | 1998-02-27 |
| MICROFUSE MEMBRANE INFUSION CATHETER (K971619) | E-Med Corp. | 1998-02-27 |
| FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE (K974067) | Merit Medical Systems, Inc. | 1998-02-27 |
| SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS (K974492) | Siemens Medical Solutions USA, Inc. | 1998-02-26 |
| BPX80 BIO-PUMP (BPX80) (K973011) | Medtronic Bio-Medicus, Inc. | 1998-02-25 |
| DYNEMO 3000 (K972798) | Sometec, Inc. | 1998-02-24 |
| SURGICAL VASCULAR CLAMP (K973080) | Walter Lorenz Surgical, Inc. | 1998-02-23 |
| LOCATOR MODEL 4036 (K972814) | Pacesetter, Inc. | 1998-02-23 |
| SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K974559) | Scimed Life Systems, Inc. | 1998-02-23 |
| CARDIO-CARD MANAGEMENT SYSTEM II (K972795) | Nasiff Assoc., Inc. | 1998-02-20 |
| SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER (K974684) | Scimed Life Systems, Inc. | 1998-02-19 |
| LATIS GRAFT CLEANING CATHETER (K973465) | Applied Medical Resources | 1998-02-19 |
| M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION (K974420) | Hewlett-Packard Co. | 1998-02-19 |
| MOBIMED SYSTEM, (PEGASUS AND POLARIS) (K973318) | Ortivus Us, Inc. | 1998-02-19 |
| BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS (K973962) | C.R. Bard, Inc. | 1998-02-19 |
| AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE (K973760) | Avecor Cardiovascular, Inc. | 1998-02-18 |
| OBSERVER * CENTRAL STATION (K972498) | Johnson & Johnson Medical, Inc. | 1998-02-17 |
| ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET (K970229) | Arrow Intl., Inc. | 1998-02-13 |
| EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (K974335) | J-Lloyd Medical, Inc. | 1998-02-13 |
| HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB (K974318) | Healthcare Service and Supply | 1998-02-13 |
| SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL (K972512) | Boston Scientific Scimed, Inc. | 1998-02-12 |
| ENSEMBLE CENTRAL STATION MONITOR (K970358) | Mennen Medical, Inc. | 1998-02-11 |
| CES MASSTRANSIT INFUSION CATHETER (K974222) | Cordis Neurovascular, Inc. | 1998-02-10 |
| PALJET-B (K973663) | Golden Gate Bio-Device | 1998-02-10 |
| 40 CC GRANDE (K974247) | Boston Scientific Corp | 1998-02-10 |
| HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01) (K972740) | Himex Production Corp. | 1998-02-06 |
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K974448) | Cordis Corp. | 1998-02-06 |
| THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) (K973669) | Micro Therapeutics, Inc. | 1998-02-06 |
| DATEX-ENGSTROM NETWORK (K974101) | Datex-Engstrom, Inc. | 1998-02-06 |
| VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300 (K970445) | Pace Tech Medical Monitors, Inc. | 1998-01-30 |
| TTM5000 TELEPHONIC EKG MONITOR (K973267) | Hds Medical, Inc. | 1998-01-29 |
| 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER (K971670) | Galix Biomedical Instrumentation, Inc. | 1998-01-29 |
| COBE OXYGENATOR PRODUCTS (K974085) | Cobe Cardiovascular, Inc. | 1998-01-27 |
| PERCUPUMP II WITH EDA (K974621) | E-Z-Em, Inc. | 1998-01-27 |
| BIOSPECTROMETER-NB OXIMETER IIII (K963903) | Hutchinson Technology, Inc. | 1998-01-27 |
| ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 (K965106) | Biotronik, Inc. | 1998-01-27 |
| HUNTLEIGH FP5000 SYSTEM MODEL FP5000 (K965153) | Huntleigh Healthcare, Inc. | 1998-01-26 |
| ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) (K965209) | Arrow Intl., Inc. | 1998-01-23 |
| FORMULA FOR ARCHIMED (K974079) | Biosound Esaote, Inc. | 1998-01-22 |
| BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT (K974155) | Baxter Healthcare Corp | 1998-01-22 |
| HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER (K974567) | Hewlett-Packard Co. | 1998-01-20 |
| METRON QA-510 SPO2 ANALYZER (K973991) | Metron U.S., Inc. | 1998-01-16 |
| REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM (K972242) | Medtronic Vascular | 1998-01-16 |
| RECHARGEABLE BATTERY PART NUMBER GL825-200 (K974061) | Alexander Mfg. Co. | 1998-01-16 |
| NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES (K973918) | Nihon Kohden America, Inc. | 1998-01-13 |
| MAGLIFE C (K972535) | Odam | 1998-01-13 |
| JOBST ATHROMBIC PUMP/SLEEVE (K970922) | Jobst A Beiersdorf Co. | 1998-01-13 |
| SINGLE LUMEN EMBOLECTOMY CATHETER (K972572) | American Biomed, Inc. | 1998-01-13 |
| LUGE GUIDE WIRE (K973945) | Scimed Life Systems, Inc. | 1998-01-12 |
| EZ HOLD 1 LBS., EZ HOLD 2 LBS (K973132) | Tz Medical, Inc. | 1998-01-12 |
| LIFE PAK 12 (K973486) | Physio-Control Corp. | 1998-01-09 |
| MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES (K973887) | Masimo Corp. | 1998-01-08 |
| STELA MODEL UJ45 PACING LEADS (K972574) | Ela Medical, Inc. | 1998-01-08 |
| AMBULATORY X-12 TELEMETRY MODULE (K974149) | Mortara Instrument, Inc. | 1998-01-08 |
| CORDIS HYDRONOL STEERABLE GUIDEWIRE (K973845) | Cordis Corp. | 1998-01-05 |
| TANGO NON-INVASIVE BLOOD PRESSURE MONITOR (K970629) | Suntech Medical Instruments, Inc. | 1998-01-02 |
| MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR (K973863) | Hi-Tronics Designs, Inc. | 1998-01-02 |
| SENTINEL RECORDER, MODELS 471/472 (K971696) | Del Mar Avionics | 1997-12-30 |
| INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 (K971775) | Cardiac Control Systems, Inc. | 1997-12-29 |
| EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (K971570) | Quinton Electrophysiology Corp. | 1997-12-29 |
| DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 (K973873) | American Telecare, Inc. | 1997-12-29 |
| RADIAL AND FEMORAL ARTERY CATHETER (K971086) | B.Braun Medical, Inc. | 1997-12-19 |
| ELECTRODE, ELECTROCARDIOGRAPH (K973727) | Don Tay Industries | 1997-12-19 |
| TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL (K973708) | Merit Medical Systems, Inc. | 1997-12-19 |
| VASOCOR PVR 100 (K973659) | Vasocor, Inc. | 1997-12-17 |
| THERMO-STAT SYSTEM (K970367) | Aquarius Medical Corp. | 1997-12-17 |
| T-REX BIOPSY FORCEPS (K973818) | Boston Scientific Corp | 1997-12-16 |
| HEARTPORT ENDOAORTIC CLAMP CATHETER (K974175) | Heartport, Inc. | 1997-12-16 |
| HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG (K973494) | Guidant Corp. | 1997-12-12 |
| IVT 0.014 PTFE-COATED TRACKWIRE (K971688) | Boston Scientific /International Technologies | 1997-12-11 |
| FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX (K964663) | Rmds, Inc. | 1997-12-11 |
| COURIER ST BALLOON DILATATION CATHETER (K972744) | Boston Scientific Corp | 1997-12-11 |
| HEART PROTECTOR (VER 1996) (K965158) | N.P.N.T., Inc. | 1997-12-09 |
| 3M CDI H/S CUVETTES WITH HEPARON TREATMENT (K973472) | 3M Healthcare | 1997-12-08 |
| COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR (K963518) | Cobe Cardiovascular, Inc. | 1997-12-08 |