| VNS THERAPY SYSTEM (P970003/S075) | LivaNova USA, Inc. | 2007-02-12 |
| LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S018) | Boston Scientific Scimed, Inc. | 2007-02-12 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S039) | Boston Scientific Corp | 2007-02-12 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S009) | Cryolife, Inc. | 2007-02-12 |
| MULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM (P020047/S007) | Abbott Vascular | 2007-02-09 |
| IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY (P970058/S024) | Hologic, Inc. | 2007-02-09 |
| MULTI-PIECE PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P810032/S053) | Alcon Laboratories | 2007-02-09 |
| COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S012) | Integra Lifesciences Corp. | 2007-02-09 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S015) | Integra Lifesciences Corp. | 2007-02-09 |
| COLLASTAT ABSORBABLE COLLAGEN AGENTS (P810006/S027) | Integra LifeSciences Corporation | 2007-02-09 |
| HELISTAT ABSORBABLE COLLAGEN AGENTS (P850010/S024) | Integra LifeSciences Corporation | 2007-02-09 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS 3000, 3000TFX(AORTIC), 6900P & 6900PTFX(MITRAL) (P860057/S037) | Edwards Lifesciences, LLC | 2007-02-08 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S002) | W. L. Gore & Associates, Inc. | 2007-02-08 |
| VIGOR/ DISCOVERY/ MERIDIAN/ PULSAR (P940031/S059) | Boston Scientific | 2007-02-08 |
| VENTAK PRX/ MINI/ CONTAK CD & CD2 (P910077/S066) | Boston Scientific | 2007-02-08 |
| VENTAK AV /PRIZM/ VITALITY (P960040/S135) | Boston Scientific | 2007-02-08 |
| TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM (P000043/S010) | Boston Scientific Corp | 2007-02-08 |
| CONTAK RENEWAL TR (P030005/S039) | Guidant Corp. | 2007-02-08 |
| CONTAK CD/CD2/RENEWAL /RENEWAL 3 (P010012/S142) | Boston Scientific Corp | 2007-02-08 |
| VNS THERAPY SYSTEM (P970003/S068) | LivaNova USA, Inc. | 2007-02-08 |
| SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S007) | Boston Scientific Corp | 2007-02-07 |
| UROVYSION BLADDER CANCER KIT (P030052/S002) | Abbott Molecular | 2007-02-06 |
| MINILINK(MODELS MMT-7703 TRANSMITTER, MMT-7705 CHARGER, MMT-7706 TEST PLUG) (P980022/S018) | Medtronic Minimed | 2007-02-06 |
| AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS (P060009/S001) | Abbott Laboratories, Inc. | 2007-02-05 |
| AXSYM ANTIBODY TO HCV (P970027/S005) | Abbott Laboratories | 2007-02-05 |
| XACT CAROTID STENT SYSTEM (P040038/S007) | Abbott Vascular, Inc. | 2007-02-05 |
| AXSYM AUSAB (P060003/S003) | Abbott Laboratories, Inc. | 2007-02-05 |
| AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS (P060012/S001) | Abbott Laboratories, Inc. | 2007-02-05 |
| ABBOTT AXSYM HBSAG ASSAY (P050049/S001) | Abbott Laboratories, Inc. | 2007-02-05 |
| XMI AND XMI-RX THROMBECTOMY CATHETERS (P980037/S019) | Boston Scientific Corp | 2007-02-02 |
| NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S002) | Medinol, Ltd. | 2007-02-02 |
| CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON) (P950020/S024) | Boston Scientific Corp | 2007-02-02 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S001) | Abbott Vascular Devices | 2007-02-02 |
| EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS (P030054/S034) | ABBOTT MEDICAL | 2007-02-02 |
| NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S003) | Medinol, Ltd. | 2007-02-02 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S016) | Boston Scientific Corp | 2007-02-01 |
| IMX PSAS (P910007/S016) | Abbott Laboratories | 2007-02-01 |
| BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS (P010062/S005) | Bausch & Lomb | 2007-02-01 |
| ABBOTT IMX FREE PSA (P980007/S008) | Abbott Laboratories | 2007-02-01 |
| ABBOTT AFP-EIA DIAGNOSTIC KIT (P820060/S021) | Abbott Laboratories | 2007-02-01 |
| SELECTED MODELS OF DUAL CHAMBER ICD DEVICES (P000009/S021) | Biotronik, Inc. | 2007-01-30 |
| SELECTED MODELS OF IPG BRADY CARDIA DEVICES (P950037/S047) | Biotronik, Inc. | 2007-01-30 |
| SELECTED MODELS OF SINGLE CHAMBER ICD DEVICES (P980023/S026) | Biotronik, Inc. | 2007-01-30 |
| VARIOUS PAVEMAKERS, CARELINK MONITOR, CARDIOSIGHT READER (P890003/S115) | Medtronic, Inc. | 2007-01-30 |
| INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS (P010031/S061) | Medtronic Cardiac Rhythm Disease Management | 2007-01-30 |
| SELECTED FAMILIES OF PACEMAKERS (P980035/S071) | Medtronic, Inc. | 2007-01-30 |
| AMPLATZER DUCT OCCLUDER (P020024/S014) | ABBOTT MEDICAL | 2007-01-30 |
| ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC IOL MODELS SN6AD3 AND MN6AD3 (P040020/S003) | Alcon Research, Ltd. | 2007-01-30 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S020) | ABBOTT MEDICAL | 2007-01-30 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROTHESIS (P870077/S022) | Edwards Lifesciences, LLC | 2007-01-29 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S038) | Edwards Lifesciences, LLC | 2007-01-29 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S011) | Edwards Lifesciences, LLC | 2007-01-29 |
| CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S011) | Edwards Lifesciences, LLC | 2007-01-29 |
| STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS (P870038/S009) | Edwards Lifesciences, LLC | 2007-01-29 |
| CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S024) | Edwards Lifesciences, LLC | 2007-01-29 |
| CONTAK RENEWAL RF PULSE GENERATORS (P010012/S102) | Boston Scientific Corp | 2007-01-26 |
| LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S027) | Biotronik, Inc. | 2007-01-26 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S001) | Stryker Corp. | 2007-01-25 |
| XACT CAROTID STENT SYSTEM (P040038/S009) | Abbott Vascular, Inc. | 2007-01-25 |
| POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-SPIROFLEX CATHETER (P980037/S017) | Boston Scientific Corp | 2007-01-25 |
| VARIOUS INSYNC FAMILIES OF CRT-ICDS (P010031/S049) | Medtronic Cardiac Rhythm Disease Management | 2007-01-24 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS (P060001) | Medtronic Vascular, Inc. | 2007-01-24 |
| ENRHYTHM (IPG) (P980035/S060) | Medtronic, Inc. | 2007-01-24 |
| SELECTED FAMILIES OF ICDS (P980016/S082) | Medtronic Cardiac Rhythm Disease Management | 2007-01-24 |
| MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S047) | Medtronic Cardiac Surgery | 2007-01-24 |
| DEXCOM STS SYSTEM (P050012/S006) | Dexcom, Inc. | 2007-01-23 |
| ELECSYS TOTAL PSA CALSET (P990056/S006) | Roche Diagnostics Corp. | 2007-01-19 |
| DIASORIN ETI-AB-EBK PLUS (P990041/S009) | DiaSorin, Inc. | 2007-01-19 |
| STARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120 (P870038/S011) | Edwards Lifesciences, LLC | 2007-01-19 |
| DIASORIN ETI-EBK PLUS (P990043/S010) | DiaSorin, Inc. | 2007-01-19 |
| CADENCE FAMILY ICDS (P910023/S130) | ABBOTT MEDICAL | 2007-01-19 |
| DIASORIN ETI-CORE-IGMK PLUS (P990044/S008) | DiaSorin, Inc. | 2007-01-19 |
| XACT CAROTID STENT SYSTEM (P040038/S008) | Abbott Vascular, Inc. | 2007-01-19 |
| ELECSYS FREE PSA CALSET AND (P000027/S004) | Roche Diagnostics Corp. | 2007-01-19 |
| EPIC HF FAMILY CRT-DS (P030054/S048) | ABBOTT MEDICAL | 2007-01-19 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S012) | Edwards Lifesciences, LLC | 2007-01-18 |
| POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER (P040002/S008) | Endologix, LLC | 2007-01-18 |
| BIOPROSTHESIS MODEL 2625,6625, VALVED CONDUIT MODEL 4300 (P870056/S025) | Edwards Lifesciences, LLC | 2007-01-18 |
| PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S039) | Edwards Lifesciences, LLC | 2007-01-18 |
| SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODELS 2650,6650 (P010041/S012) | Edwards Lifesciences, LLC | 2007-01-18 |
| DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S023) | Edwards Lifesciences, LLC | 2007-01-18 |
| RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS (P040012/S025) | Abbott Vascular | 2007-01-18 |
| SILASTIC BALL HEART VALVE PROSTHESIS (P870038/S010) | Edwards Lifesciences, LLC | 2007-01-18 |
| MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S023) | Medtronic Vascular | 2007-01-18 |
| HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S009) | Hologic, Inc. | 2007-01-17 |
| AMO SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S009) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| AMO SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S010) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIORCHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A & 913A, TECNIS Z9000 & Z9001 (P990080/S014) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| ARRAY MULTIFOCAL FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER IOL, CEEON 911A & 913A, TECNIS Z9000 & Z9001 (P990080/S013) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A ,913A & TECNIS Z9000, Z9001 (P990080/S015) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S002) | Abbott Vascular Devices | 2007-01-16 |
| FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A,913A & TECNIS Z9000 & Z9001 (P990080/S016) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| FOLDABLE ULTAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A,913A 7 TECNIS Z9000,Z9001 (P990080/S018) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A, 913A & TECNIS Z9000,Z9001 (P990080/S017) | Johnson & Johnson Surgical Vision, Inc. | 2007-01-16 |
| LOGICON CARIES DETECTOR (P980025/S001) | Carestream Dental, LLC | 2007-01-12 |
| ST JUDE MEDICAL ICDS & CRT-DS (P910023/S129) | ABBOTT MEDICAL | 2007-01-11 |
| ST JUDE MEDICAL ICDS & CRT-DS (P030054/S047) | ABBOTT MEDICAL | 2007-01-11 |
| PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY (P990081/S003) | Ventana Medical Systems, Inc. | 2007-01-11 |
| KAPPA 700 IPG, KAPPA 900 IPG, ENPULSE IPG, ADAPATA/ VERSA/ SENSIA IPG (P980035/S070) | Medtronic, Inc. | 2007-01-11 |
| INSYNC ICD (P010031/S060) | Medtronic Cardiac Rhythm Disease Management | 2007-01-11 |