| AMBU WHITE SENSOR CFM, CFL (K052944) | Ambu A/S | 2006-10-25 |
| AMBU BLUE SENSOR NEO AND NEO X (K053550) | Ambu A/S | 2006-10-25 |
| SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 (K061416) | Medtronic Vascular | 2006-10-25 |
| TELEVISIT (K062338) | PHD Medical | 2006-10-25 |
| MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH (K062446) | Terumo Medical Corp. | 2006-10-23 |
| SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K061188) | Foxhollow Technologies, Inc. | 2006-10-23 |
| OCCLUSION BALLOON (K062202) | Boston Scientific Corp | 2006-10-20 |
| TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (K062870) | Kensey Nash Corp. | 2006-10-20 |
| MODIFICATION TO GLIDESHEATH (K062858) | Terumo Medical Corp. | 2006-10-20 |
| REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 (K062251) | St Jude Medical | 2006-10-20 |
| NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION (K060967) | Stereotaxis, Inc. | 2006-10-19 |
| ADMIRAL XTREME PTA CATHETER (K062809) | Invatec Innovative Technologies | 2006-10-18 |
| MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 (K062268) | Philips Medical Systems North America Co. | 2006-10-18 |
| FOX SV PTA CATHETER (K062843) | Abbott Laboratories | 2006-10-17 |
| SERENO ELECTRONIC STETHOSCOPE (K062481) | Pishon High Tech Co., Ltd. | 2006-10-16 |
| CONFIDANT 2.0 (K062215) | Confidant, Inc. | 2006-10-16 |
| PMP4 APPLICATION (K061428) | Card Guard Scientific Survival , Ltd. | 2006-10-16 |
| DMS 300-2, 300-3 AND 300-4 (K062959) | Diagnostic Monitoring Software | 2006-10-16 |
| HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR (K061070) | Hansen Medical, Inc. | 2006-10-13 |
| ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 (K062144) | Invivo Corporation | 2006-10-12 |
| CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 (K061046) | Cardiomems, Inc. | 2006-10-12 |
| BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 (K060538) | Beaverite International Limited | 2006-10-10 |
| MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER (K062609) | AngioDynamics, Inc. | 2006-10-06 |
| CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES (K060927) | Ceres Medical Systems, LLC | 2006-10-06 |
| FLEXITOUCH SYSTEM (K062818) | Tactile Systems Technology, Inc. | 2006-10-06 |
| OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (K061585) | Hospira, Inc. | 2006-10-05 |
| TREASURE (K061984) | Asahi Intecc Co., Ltd. | 2006-10-05 |
| VASORING* VRC VASCULAR RING CONNECTOR (K061626) | Sunwei Tech Co. , Ltd. | 2006-10-05 |
| SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM (K062387) | Boston Scientific | 2006-10-05 |
| DLM112 DAYLINK MONITOR (K062304) | Rtx Healthcare A/S | 2006-09-29 |
| NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L (K062462) | Jawon Medical Co., Ltd. | 2006-09-29 |
| MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (K062095) | Spacelabs Medical, Inc. | 2006-09-29 |
| CLIRPATH TURBO PERIPHERAL CATHETERS (K060012) | Spectranetics Corp. | 2006-09-29 |
| DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES (K062576) | GE Healthcare | 2006-09-29 |
| PULSE OXIMETER ADAPTER CABLES (K052544) | American I.V. Products, Inc. | 2006-09-29 |
| MODIFICATION TO LUCAS (K062401) | Jolife AB | 2006-09-28 |
| MODIFICATION TO STOCKERT S5 SYSTEM (K062396) | Sorin Group Deutschland GmbH | 2006-09-28 |
| MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH (K062429) | Edwards Lifesciences Research Medical | 2006-09-27 |
| CKIS-004A INJECTOR SYNCHRONIZATION OPTION (K061976) | Toshiba America Medical Systems, In.C | 2006-09-27 |
| SCD GARMENT, MODEL VP530 (K061967) | Compression Therapy Concepts, Inc. | 2006-09-25 |
| TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT (K062342) | Sentra Medical Devices, LLC | 2006-09-25 |
| HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 (K062119) | Medical Products Mfg., LLC | 2006-09-22 |
| ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (K062531) | Cordis Corp., A Johnson & Johnson Co. | 2006-09-22 |
| TYTAN BLOOD PRESSURE CUFF (K062238) | Tytan Medical Corp. | 2006-09-21 |
| THERMOSUIT SYSTEM (K061023) | Life Recovery Systems Hd, LLC | 2006-09-20 |
| MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K062594) | Boston Scientific Corporation | 2006-09-20 |
| THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS (K062283) | Philips Medical Systems North America, Inc. | 2006-09-20 |
| RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 (K062275) | Kerberos Proximal Solutions, Inc. | 2006-09-20 |
| FETCH ASPIRATION CATHETER (K062172) | Possis Medical, Inc. | 2006-09-20 |
| TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT (K061573) | Hospira, Inc. | 2006-09-19 |
| SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 (K062278) | Spacelabs Medical, Inc. | 2006-09-19 |
| PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES (K061790) | Protein Polymer Technologies, Inc. | 2006-09-19 |
| MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 (K061502) | Medic4all (Israel) , Ltd. | 2006-09-15 |
| MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM (K061741) | GE Healthcare | 2006-09-15 |
| TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + (K061780) | Rozinn Electronics, Inc. | 2006-09-15 |
| FUSION (K061557) | Medwave, Inc. | 2006-09-15 |
| BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE (K061932) | Cardiopulmonary Corp. | 2006-09-14 |
| PROXIS SYSTEM, MODEL EPS101 (K060651) | St Jude Medical | 2006-09-13 |
| SPECTRUM M2 MONITOR (K062468) | Spectrum Medical, Llp | 2006-09-13 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC (K061471) | Microlife Intellectual Property GmbH | 2006-09-11 |
| 5F SHERPA ACTIVE NX GUIDE CATHETER (K062420) | Medtronic Vascular | 2006-09-08 |
| PROXIS SYSTEM (K052523) | Velocimed, Inc. | 2006-09-07 |
| PHILIPS MP5 INTELLIVUE PATIENT MONITOR (K062392) | Philips Medizin Systeme Boeblingen GmbH | 2006-09-06 |
| MEDTRONIC EXPORT XT CATHETER (K061958) | Medtronic Vascular | 2006-09-05 |
| PULSE OXIMETER, MODEL PM-50 (K061442) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-09-05 |
| FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 (K061960) | Cas Medical Systems, Inc. | 2006-09-05 |
| BOOMERANG WIRE (K061075) | Cardiva Medical, Inc. | 2006-09-01 |
| BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 (K053556) | Jawon Medical Co., Ltd. | 2006-08-31 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K061045) | Alliance Medical Corp. | 2006-08-31 |
| TELAHEART DIGITAL RECORDER (K061293) | North East Monitoring, Inc. | 2006-08-25 |
| PREMIER 11 HOLTER (K062088) | Diagnostic Monitoring Software | 2006-08-25 |
| CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR (K062381) | Terumo Cardiovascular Systems Corp. | 2006-08-24 |
| ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER (K061733) | AngioDynamics, Inc. | 2006-08-24 |
| MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 (K062145) | Acumen Medical, Inc. | 2006-08-23 |
| JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 (K061628) | Maquet Cardiopulmonary, AG | 2006-08-22 |
| NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS (K061866) | Thermotek, Inc. | 2006-08-22 |
| VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K062134) | Edwards Lifesciences, LLC | 2006-08-22 |
| TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 (K061369) | Cardiacassist, Inc. | 2006-08-22 |
| MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 (K061959) | Mytech Technology Co., Ltd. | 2006-08-22 |
| CG-6108 ARRHYTHMIA ECG EVENT RECORDER (K060911) | Card Guard Scientific Survival , Ltd. | 2006-08-22 |
| ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480) | Medtronic, Ireland | 2006-08-21 |
| 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 (K062084) | Acumen Medical, Inc. | 2006-08-18 |
| LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K061279) | Little Doctor (Shanghai) Electronic | 2006-08-18 |
| CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA (K062168) | Nemoto Kyorindo Co., Ltd. | 2006-08-18 |
| ZOLL R SERIES DEFIBRILLATOR (K060559) | ZOLL Medical Corporation | 2006-08-17 |
| DMS 300-7 (K062007) | Diagnostic Monitoring Software | 2006-08-16 |
| REFSTAR EXTERNAL REFERENCE PATCH (K061468) | Biosense Webster, Inc. | 2006-08-14 |
| NELLCOR OXIMAX N-600X PULSE OXIMETER (K060576) | Nellcor Puritan Bennett, Inc. | 2006-08-14 |
| PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS (K061610) | Philips Medizin Systeme Boeblingen GmbH | 2006-08-14 |
| ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S (K061463) | Biosense Webster, Inc. | 2006-08-14 |
| ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 (K061760) | K-Jump Health Co., Ltd. | 2006-08-14 |
| SPIDERX EMBOLIC PROTECTION DEVICE (K062201) | Ev3, Inc. | 2006-08-11 |
| HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS (K061707) | Philips Medical Systems | 2006-08-11 |
| JOSTRA HLM TUBING SETS WITH SAFELINE COATING (K061832) | Maquet Cardiopulmonary, AG | 2006-08-11 |
| WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE (K061994) | GE Healthcare | 2006-08-11 |
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) (K061332) | Boston Scientific Corp | 2006-08-11 |
| MODIFICATION TO GUARDDOG OCCLUSION SYSTEM (K062220) | Possis Medical, Inc. | 2006-08-11 |
| DM-3000 DIGITAL BLOOD PRESSURE MONITOR (K061086) | Nihon Seimitsu Sokki Co., Ltd. | 2006-08-10 |
| EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 (K062126) | Biosphere Medical, Inc. | 2006-08-09 |
| CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) (K042850) | Stereotaxis, Inc. | 2006-08-09 |