| DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 (K990110) | Maersk Medical A/S | 1999-12-06 |
| OPTISTAR MR INJECTOR SYSTEM (K984088) | Mallinckrodt Inc., Liebel-Flarsheim Business | 1999-12-06 |
| DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 (K990112) | Maersk Medical A/S | 1999-12-06 |
| MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K993729) | Biosense Webster, Inc. | 1999-12-03 |
| HL148 & HL168 (K990807) | Health & Life Co., Ltd. | 1999-12-03 |
| COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED (K993001) | Cobe Cardiovascular, Inc. | 1999-12-03 |
| SPACELABS MEDICAL DISPOSABLE SP02 SENSOR (K981655) | Spacelabs Medical, Inc. | 1999-12-03 |
| ENSITE 3000 SYSTEM (K992479) | Endocardial Solutions, Inc. | 1999-12-02 |
| HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A (K992977) | Hewlett-Packard Co. | 1999-12-01 |
| DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 (K993890) | Nihon Seimitsu Sokki Co., Ltd. | 1999-12-01 |
| MAC-LAB SYSTEM (K992948) | General Electric Medical Systems Information Techn | 1999-11-29 |
| ECG ELECTRODE (VARIOUS) (K991105) | Conmedcorp | 1999-11-26 |
| DASH 3000 PATIENT MONITOR (K992929) | General Electric Medical Systems Information Techn | 1999-11-26 |
| CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 (K992965) | Cordis Webster, Inc. | 1999-11-26 |
| SYNEFLASH & SYNEVIEW (K990727) | Ela Medical, Inc. | 1999-11-26 |
| MEDRAD ENVISION CT INJECTOR SYSTEM (K993728) | Medrad, Inc. | 1999-11-26 |
| DIGITRAKPLUS HOLTER RECORDER (K993617) | Braemar Corp. | 1999-11-24 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER (K993648) | Boston Scientific Corporation Northwest Technology | 1999-11-24 |
| N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS (K993637) | Nellcor Puritan Bennett, Inc. | 1999-11-24 |
| DXP1000 HOLTER RECORDER (K993618) | Braemar Corp. | 1999-11-24 |
| STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (K990512) | Stoeckert Instrumente | 1999-11-23 |
| IBC VENT VALVE, MODEL 1400 (K992964) | International Biophysics Corp. | 1999-11-19 |
| ALARMVIEW SYSTEM (K992848) | Data Critical Corp. | 1999-11-19 |
| SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS (K992832) | Sulzermedica | 1999-11-19 |
| MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES (K993555) | Masimo Corp. | 1999-11-19 |
| MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION (K991786) | General Electric Medical Systems Information Techn | 1999-11-18 |
| SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 (K991059) | Spectranetics Corp. | 1999-11-16 |
| UNI-GRAFT K DV PATCH (K992776) | Atrium Medical Corp. | 1999-11-16 |
| IMPRESARIO (K993620) | Del Mar Medical Systems, LLC | 1999-11-12 |
| CONSTELLATION CATHETERS, MODEL 8039 (K992777) | Boston Scientific Corp | 1999-11-12 |
| LEAD STYLET,MODELS 6505,6506,6507,6508 (K992863) | Guidant Corp. | 1999-11-12 |
| PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434) | Biotronik, Inc. | 1999-11-10 |
| COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT (K992906) | Olson Medical Sales, Inc. | 1999-11-10 |
| VACUUM ASSIST STABILIZER (K992833) | Cardio Thoracic Systems | 1999-11-10 |
| LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (K992857) | Rocky Mountain Research, Inc. | 1999-11-10 |
| HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A (K992674) | Hewlett-Packard GmbH | 1999-11-08 |
| HP M2600A VIRIDIA TELEMETRY SYSTEM (K993516) | Hewlett-Packard Co. | 1999-11-08 |
| ULTRA-CBX (K991486) | Medcanica, Inc. | 1999-11-05 |
| MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE (K990103) | Sorin Biomedical, Inc. | 1999-11-05 |
| ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE (K992373) | C.R. Bard, Inc. | 1999-11-05 |
| MUSE CARDIOVASCULAR INFORMATION SYSTEM (K992637) | General Electric Medical Systems Information Techn | 1999-11-03 |
| BARD HYDROPHILIC COATED GUIDE WIRES (K993000) | C.R. Bard, Inc. | 1999-11-02 |
| DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR (K992599) | Dideco S.P.A. | 1999-11-01 |
| DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (K992323) | Datex-Ohmeda, Inc. | 1999-11-01 |
| PROWLER PLUS INFUSION CATHETER (K993266) | Cordis Neurovascular, Inc. | 1999-10-28 |
| ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE (K992169) | Advanced Cardiovascular Systems, Inc. | 1999-10-28 |
| DUAL LUMEN CATHETER, MODEL DL-35-90 (K991601) | Endologix, Inc. | 1999-10-28 |
| CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM (K993245) | Alba Critical Care, Ltd. | 1999-10-28 |
| SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES (K982521) | Leonhard Lang Co. | 1999-10-26 |
| INTELLISYSTEM II COLOR MONITOR (K993341) | Merit Medical Systems, Inc. | 1999-10-25 |
| SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER (K990713) | Spectranetics Corp. | 1999-10-22 |
| HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A (K993171) | Hewlett-Packard Co. | 1999-10-21 |
| ZOLL M SERIES 12SL ANALYSIS OPTION (K991556) | Zoll Medical Corp | 1999-10-21 |
| .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI (K993257) | Micro Therapeutics, Inc. | 1999-10-21 |
| TES-20 (K992425) | Tes Electrical Electronic Corp. | 1999-10-19 |
| PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (K992478) | Hewlett-Packard, Healthcare Solutions Group | 1999-10-15 |
| LUMA-CATH FIXED CURVE EP CATHETERS (K991025) | Irvine Biomedical, Inc. | 1999-10-15 |
| DAIWA MODEL 180 (K983616) | Daiwa Products, Inc. | 1999-10-15 |
| VISTA BRITE TIP CATHETERS (K992673) | Cordis Corp. | 1999-10-12 |
| ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 (K992056) | Sulzer Carbomedics, Inc. | 1999-10-12 |
| MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) (K992238) | Masimo Corp. | 1999-10-08 |
| CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS (K992347) | Cordis Corp. | 1999-10-08 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE (K992340) | Masimo Corp. | 1999-10-08 |
| ANEROID SPHYGMOMANOMETER (K990638) | Genmed, Inc. | 1999-10-07 |
| COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR (K991452) | Cobe Cardiovascular, Inc. | 1999-10-07 |
| ECG MINIMONITOR, MODEL CG-5000 (K992696) | Card Guard Scientific Survival , Ltd. | 1999-10-07 |
| INTRODUCER SHEATH, VESSEL DILATOR (K992309) | Boston Scientific Corp | 1999-10-07 |
| MBA (K993057) | Merit Medical Systems, Inc. | 1999-10-05 |
| CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 (K991531) | Cordis Webster, Inc. | 1999-10-04 |
| ADVANTA GRAFT (>6MM) (K992960) | Atrium Medical Corp. | 1999-10-01 |
| ADVANTA GRAFT (<6MM) (K992958) | Atrium Medical Corp. | 1999-10-01 |
| T-ANASTAFLO (K990396) | Edwards Lifesciences Research Medical | 1999-10-01 |
| POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (K990276) | Porous Media Corp. | 1999-10-01 |
| WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (K991540) | AngioDynamics, Inc. | 1999-09-29 |
| INTRAMAX ITI GUIDE CATHETER (K992622) | Intratherapeutics, Inc. | 1999-09-29 |
| CARTO EP NAVIGATION SYSTEM (K992968) | Biosense Webster, Inc. | 1999-09-29 |
| KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 (K992079) | The Kendall Company, L.P. | 1999-09-29 |
| AGILITY STEERABLE GUIDEWIRE (K991646) | Cordis Neurovascular, Inc. | 1999-09-23 |
| HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 (K992559) | Jostra Bentley | 1999-09-20 |
| STATVIEW SYSTEM (K990378) | Data Critical Corp. | 1999-09-20 |
| CARDIOPHONICS 1000 MEMORY MONITOR (K992772) | Rlt Medical Assoc., Inc. | 1999-09-17 |
| ECHOFLOW DOPPLER BLOOD VELOCITY METER (K990642) | Echocath, Inc. | 1999-09-16 |
| BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM (K983717) | Aerotel Medical Systems (1998) , Ltd. | 1999-09-16 |
| AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) (K992910) | Medtronic Vascular | 1999-09-15 |
| CORDIS EXTREME PTA BALLOON CATHETER (K992825) | Cordis Corp. | 1999-09-15 |
| PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196) | Tz Medical, Inc. | 1999-09-15 |
| PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232) | Tz Medical, Inc. | 1999-09-15 |
| MADTRONIC DLP ARTERIAL CANNULAE (K991066) | Medtronic Vascular | 1999-09-14 |
| MEDTRONIC GT2 FUSION GUIDE WIRES (K992237) | Medtronic Vascular | 1999-09-09 |
| SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS (K992640) | Minumys Surgical, Inc. | 1999-09-08 |
| PTFE RINGED GORE-TEX VASCULAR GRAFT (K991683) | W. L. Gore & Associates, Inc. | 1999-09-08 |
| CAPIOX SX10 HARDSHELL RESEVOIR (K991973) | Terumo Medical Corp. | 1999-09-03 |
| ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (K990762) | Zoll Medical Corp | 1999-09-03 |
| LIFEPAK 12 BIPHASIC (K991910) | Physio-Control Corp. | 1999-09-03 |
| MODIFICATION OF NOGA (K990494) | Biosense, Inc. | 1999-09-03 |
| NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K990338) | Physio-Control Corp. | 1999-09-01 |
| A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE (K992808) | A&D Medical Div. | 1999-09-01 |
| CUFF-ABLE PLUS (K990412) | Vital Signs, Inc. | 1999-09-01 |
| HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A (K992636) | Hewlett-Packard Co. | 1999-08-31 |
| EQUINOX OCCLUSION BALLOON SYSTEM (K990487) | Micro Therapeutics, Inc. | 1999-08-31 |