| CORMET HIP RESURFACING SYSTEM (P050016/S006) | Corin USA | 2009-12-31 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S013) | Smith & Nephew, Inc. | 2009-12-31 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S175) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| INSYNC/INSYNC II/INSYNC III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO & II/MAXIMO II/CONSULTA (P010031/S174) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S102) | Medtronic, Ireland | 2009-12-30 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S214) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S037) | Medtronic, Ireland | 2009-12-30 |
| CARPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S036) | Edwards Lifesciences, LLC | 2009-12-30 |
| MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR (P980016/S215) | Medtronic Cardiac Rhythm Disease Management | 2009-12-30 |
| CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S033) | Edwards Lifesciences, LLC | 2009-12-30 |
| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S021) | Edwards Lifesciences, LLC | 2009-12-30 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S022) | Edwards Lifesciences, LLC | 2009-12-30 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S010) | Allergan | 2009-12-29 |
| APLIGRAF (P950032/S054) | Organogenesis, Inc. | 2009-12-29 |
| FLEXTOME CUTTING BALLOON (P950020/S036) | Boston Scientific Corp | 2009-12-28 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S011) | Allergan | 2009-12-24 |
| AMS UROLUME ENDOPROSTHESIS (P920023/S026) | Boston Scientific Corp | 2009-12-23 |
| TELIGEN ICDS (P960040/S211) | Boston Scientific | 2009-12-23 |
| SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S017) | Hologic, Inc. | 2009-12-23 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S010) | Cerenovus, Inc. | 2009-12-23 |
| CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S006) | Syncardia Systems, LLC | 2009-12-23 |
| KARL STORZ AUTOFLUORESCENCE SYSTEM (P020008/S002) | KARL STORZ Endoscopy-America, Inc. | 2009-12-23 |
| APLIGRAF (P950032/S055) | Organogenesis, Inc. | 2009-12-23 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S009) | Siemens Healthcare Diagnostics, Inc. | 2009-12-23 |
| CONCERTO CRT ICD/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S173) | Medtronic Cardiac Rhythm Disease Management | 2009-12-23 |
| COGNIS CRT-DS (P010012/S228) | Boston Scientific Corp | 2009-12-23 |
| SECURA DR/VR/VIRTUOSO DR/VR ICD/MAXIMO II DR/VR/VIRTUOSO II VR/DR (P980016/S213) | Medtronic Cardiac Rhythm Disease Management | 2009-12-23 |
| COGNIS ICD (P010012/S225) | Boston Scientific Corp | 2009-12-22 |
| MEDTRONIC ATTAIN STARFIX LEAD MODEL 4195 (P060039/S008) | Medtronic, Inc. | 2009-12-22 |
| ACUITY SPIRAL LEAD DEVICE (P010012/S224) | Boston Scientific Corp | 2009-12-22 |
| PERCLOSE PROGLIDE SUTURE/PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S070) | Abbott Vascular, Inc. | 2009-12-22 |
| ADAPTA/VERSA/SENSIA/RELIA (P980035/S149) | Medtronic, Inc. | 2009-12-22 |
| DEMA IPG; C-SERIES IPG; T-SERIES IPG (P990001/S058) | Medtronic, Inc. | 2009-12-22 |
| EXABLATE 2100 SYSTEM (P040003/S006) | Insightec, Ltd. | 2009-12-22 |
| EUFLEXXA ( 1% SODIUM HYALURONATE) (P010029/S011) | Ferring Pharmaceuticals, Inc. | 2009-12-22 |
| TELIGEN (P960040/S209) | Boston Scientific | 2009-12-22 |
| COGNIS (P010012/S227) | Boston Scientific Corp | 2009-12-22 |
| GEM II/MARQUIS/MAXIMO/MAXIMO II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II DR/VR/SECURA DR/VR (P980016/S212) | Medtronic Cardiac Rhythm Disease Management | 2009-12-22 |
| TELIGEN (P960040/S210) | Boston Scientific | 2009-12-22 |
| VITALITY AND CONFIENT (P960040/S207) | Boston Scientific | 2009-12-22 |
| INSYNC/INSYNC MARQUIS/II/III/INSYNC PTOTECT II/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-D (P010031/S172) | Medtronic Cardiac Rhythm Disease Management | 2009-12-22 |
| CONTAK RENEWAL TR (P030005/S059) | Guidant Corp. | 2009-12-22 |
| LCS TOTAL KNEE SYSTEM (P830055/S113) | Depuy, Inc. | 2009-12-22 |
| INSYNC & INSYNC III CRT-PS (P010015/S074) | Medtronic, Inc. | 2009-12-22 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S148) | Medtronic, Inc. | 2009-12-22 |
| LIVIAN AND CONTAK RENEWAL (P010012/S223) | Boston Scientific Corp | 2009-12-22 |
| COGNIS (P010012/S226) | Boston Scientific Corp | 2009-12-22 |
| TELIGEN FAMILY OF ICDS (P960040/S208) | Boston Scientific | 2009-12-22 |
| KAPPA 400 DR & KAPPA 400 SR IPGS (P970012/S059) | Medtronic, Inc. | 2009-12-22 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S029) | Abbott Vascular, Inc. | 2009-12-22 |
| TRILOGY AB ACETABULAR SYSTEM (P040048/S012) | Zimmer, Inc. | 2009-12-22 |
| MEDTRONIC ACTIVA DEEP BRAIN STIMULATION DEVICES (P960009/S072) | Medtronic, Inc. | 2009-12-18 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S009) | Bard Peripheral Vascular | 2009-12-18 |
| COSEAL SURGICAL SEALANT (P030039/S014) | Baxter Bio Science | 2009-12-18 |
| HALL EASY-FIT PROSTHETIC HEART VALVE (P790018/S051) | Medtronic Cardiac Surgery | 2009-12-18 |
| MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM (P070007/S014) | Medtronic Vascular | 2009-12-17 |
| VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM (P040016/S045) | Boston Scientific Scimed, Inc. | 2009-12-17 |
| MEDTRONIC VACSULAR TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S013) | Medtronic Vascular | 2009-12-17 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT (P060008/S033) | Boston Scientific Corp | 2009-12-17 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S032) | Boston Scientific Corp | 2009-12-17 |
| PTCA CATHETERS (P860019/S246) | Scimed Life Systems, Inc. | 2009-12-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S018) | Zoll Manufacturing Corporation | 2009-12-17 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT (P030025/S079) | Boston Scientific Corp | 2009-12-17 |
| GENESEARCH BREAST LYMPH NODE (BLN) ASSAY (P060017/S004) | Janssen Diagnostics | 2009-12-17 |
| VERIFLEX LIBERTE MONORAIL & OTW CORONARY STENT SYSTEM (P040016/S046) | Boston Scientific Scimed, Inc. | 2009-12-17 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S009) | Ferring Pharmaceuticals, Inc. | 2009-12-16 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S015) | Zoll Manufacturing Corporation | 2009-12-16 |
| AFFINITY/INTEGRITY/VICTORY/ACCENT FAMILY OF PACEMAKERS (P880086/S182) | ABBOTT MEDICAL | 2009-12-16 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S013) | Zoll Manufacturing Corporation | 2009-12-16 |
| BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S014) | Altacor , Ltd. | 2009-12-16 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS (P030035/S063) | ABBOTT MEDICAL | 2009-12-16 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS (P010052/S004) | Siemens Healthcare Diagnostics Products, Ltd. | 2009-12-16 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S015) | Medtronic Vascular | 2009-12-15 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S014) | Medtronic Vascular | 2009-12-15 |
| ANEURX AAADVANTAGE STENT GRAFT SYSTEM (P990020/S038) | Medtronic Vascular | 2009-12-15 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S103) | Medtronic, Ireland | 2009-12-15 |
| FLAIR ENDOVACULAR STENT GRAFT (P060002/S008) | Bard Peripheral Vascular | 2009-12-15 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S022) | W. L. Gore & Associates, Inc. | 2009-12-14 |
| TELIGEN PACEMAKER (P960040/S206) | Boston Scientific | 2009-12-14 |
| OVATIO VR AND OVATIO DR ICDS (P980049/S051) | MicroPort CRM USA, Inc. | 2009-12-14 |
| NAVISTAR (4MM, DS, THERMOCOOL AND RMT) (P010068/S018) | Biosense Webster, Inc. | 2009-12-14 |
| NAVISTAR (4MM, DS, THERMOCOOL AND RMT) (P040036/S014) | Biosense Webster, Inc. | 2009-12-14 |
| NAVISTAR THERMOCOOL AND NAVISTAR RMT THERMOCOOL CATHETERS (P990025/S022) | Biosense Webster, Inc. | 2009-12-14 |
| ELA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P060027/S016) | MicroPort CRM USA, Inc. | 2009-12-14 |
| COGNIS PACEMAKER (P010012/S222) | Boston Scientific Corp | 2009-12-14 |
| EZ STEER NAV AND EZ STEER NAV DS CATHETERS (P030031/S021) | Biosense Webster, Inc. | 2009-12-14 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES HEART VALVES (P860057/S055) | Edwards Lifesciences, LLC | 2009-12-11 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S021) | Cordis US Corporation | 2009-12-11 |
| DURASTAR/FIRESTAR RX PTCA DILATATION CATHETERS (P880003/S099) | Cordis Corp. | 2009-12-11 |
| RIGID GAS PERMEABLE CONTACT LENS (P870024/S047) | CooperVision, Inc. | 2009-12-11 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S014) | Smith & Nephew, Inc. | 2009-12-11 |
| DEFLUX INJECTABLE GEL (P000029/S061) | Palette Life Sciences | 2009-12-10 |
| ABBOTT ARCHITECT CORE ASSAY (P080023/S001) | Abbott Laboratories | 2009-12-10 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S052) | Cochlear Americas | 2009-12-10 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S002) | Integra LifeSciences Corporation | 2009-12-10 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S008) | Srs Medical | 2009-12-09 |
| PEPGEN P-15 FLOW (P990033/S016) | Ceramed Corp. | 2009-12-09 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS (P860057/S053) | Edwards Lifesciences, LLC | 2009-12-08 |
| LIFESTENT AND LIFESYENT XL VASCULAR STENT SYSTEMS (P070014/S006) | Bard Peripheral Vascular, Inc. | 2009-12-08 |
| LCS TOTAL KNEE SYSTEM ¿ P.F.C. SIGMA RPF FEMORAL COMPONENTS (P830055/S112) | Depuy, Inc. | 2009-12-08 |