| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S019) | Edwards Lifesciences, LLC | 2008-12-31 |
| CYLOS/PROTOS/AXIOS/PHILOS II & PHILOS/PHILOS DR-T PULSE GENERATORS (P950037/S063) | Biotronik, Inc. | 2008-12-31 |
| STRATOS LV (T) PULSE GENERATOR (P070008/S006) | Biotronik, Inc. | 2008-12-31 |
| DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM (P030009/S030) | Medtronic, Ireland | 2008-12-31 |
| CAEPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S032) | Edwards Lifesciences, LLC | 2008-12-31 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S020) | Edwards Lifesciences, LLC | 2008-12-31 |
| CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S031) | Edwards Lifesciences, LLC | 2008-12-31 |
| TENDRIL ST LEAD (P960013/S041) | ABBOTT MEDICAL | 2008-12-31 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S012) | DePuy Orthopaedics, Inc. | 2008-12-30 |
| IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA (P060005/S001) | Siemens Medical Solutions Diagnostics Limited | 2008-12-30 |
| COAPTITE INJECTABLE IMPLANT (P040047/S010) | Merz North America, Inc. | 2008-12-30 |
| IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA (P930027/S007) | Siemens Healthcare Diagnostics, Inc. | 2008-12-30 |
| TMR HOLMIUM LASER SYSTEM (P970029/S013) | Cryolife, Inc. | 2008-12-30 |
| C-SERIES & T-SERIES (P990001/S047) | Medtronic, Inc. | 2008-12-24 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S098) | Medtronic, Ireland | 2008-12-24 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S008) | Natus Medical Incorporated | 2008-12-24 |
| KAPPA 600/650/700/800/900/ENPULSE/ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S124) | Medtronic, Inc. | 2008-12-24 |
| KAPPA 400 DR/SR (P970012/S040) | Medtronic, Inc. | 2008-12-24 |
| LUMOS & TACHOS & BELOS FAMILY OF ICDS & XELOS DR-T (P000009/S029) | Biotronik, Inc. | 2008-12-24 |
| SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS (P910066/S025) | Djo, LLC | 2008-12-24 |
| TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS (P050023/S015) | Biotronik, Inc. | 2008-12-24 |
| KAPPA 400 DR/SR IPG (P970012/S048) | Medtronic, Inc. | 2008-12-24 |
| INSYNC & INSYNC III (P010015/S050) | Medtronic, Inc. | 2008-12-24 |
| NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS (P030031/S013) | Biosense Webster, Inc. | 2008-12-24 |
| INSYNC SENTRY/MAXIMO CRT-D/INSYNC II PROTECT & MARQUIS/CONCERTO ICD (P010031/S136) | Medtronic Cardiac Rhythm Disease Management | 2008-12-24 |
| PRECISE NITINOL STENT SYSTEM/PRECISE RX NITINOL STENT SYSTEM/PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S016) | Cordis US Corporation | 2008-12-24 |
| MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC/ENTRUST/VIRTUOSO ICDS (P980016/S169) | Medtronic Cardiac Rhythm Disease Management | 2008-12-24 |
| KAPPA 600/700/650/800/900 IPG & ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPG (P980035/S123) | Medtronic, Inc. | 2008-12-24 |
| VARIOUS FAMILIES OF PACEMAKERS (P990001/S041) | Medtronic, Inc. | 2008-12-24 |
| DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS (P030009/S028) | Medtronic, Ireland | 2008-12-24 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S109) | Medtronic, Inc. | 2008-12-24 |
| CURRENT RF AND PROMOTE RF FAMILY OF DEVICES (P910023/S195) | ABBOTT MEDICAL | 2008-12-23 |
| SENSAR SOFT ACRULIC INTRAOCULAR LENSES (P980040/S026) | Johnson & Johnson Surgical Vision, Inc. | 2008-12-23 |
| TECHNIS ACRYLIC IOL (P990080/S032) | Johnson & Johnson Surgical Vision, Inc. | 2008-12-23 |
| RESTYLANE INJECTABLE GEL (P040024/S031) | Q-Med AB | 2008-12-23 |
| CURRENT RF AND PROMOTE RF FAMILY OF DEVICES (P030054/S110) | ABBOTT MEDICAL | 2008-12-23 |
| RESTYLANE INJECTABLE GEL (P040024/S030) | Q-Med AB | 2008-12-23 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S006) | Alcon Laboratories | 2008-12-23 |
| REZOOM MULTIFOCAL ACRYLIC IOL (P960028/S031) | Johnson & Johnson Surgical Vision, Inc. | 2008-12-23 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S027) | Alcon Research, Ltd. | 2008-12-23 |
| VISCOAT, DUOVISC, AND DISCOVIS OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S039) | Alcon Laboratories | 2008-12-23 |
| CONTAK RENEWAL RF FAMILY (P010012/S198) | Boston Scientific Corp | 2008-12-22 |
| SELENIA DIMENSIONS (2D) FFDM SYSTEM (P010025/S013) | Hologic, Inc. | 2008-12-22 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S013) | Coloplast Corp. | 2008-12-22 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S003) | Roche Molecular Systems, Inc. | 2008-12-22 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S019) | Roche Molecular Systems, Inc. | 2008-12-22 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S002) | Roche Molecular Systems, Inc. | 2008-12-22 |
| ACRYSOF IQ RESTOR IOLS +3.0 D (P040020/S012) | Alcon Research, Ltd. | 2008-12-22 |
| SALINE FILLED TESTICULAR PROSTHESIS (P020003/S006) | Coloplast Corp. | 2008-12-22 |
| CADENCE ICD SYSTEM (P910023/S197) | ABBOTT MEDICAL | 2008-12-19 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S035) | Med-El Corp. | 2008-12-19 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S012) | Coloplast Corp. | 2008-12-19 |
| VNS THERAPY PERENNIAFLEX (P970003/S100) | LivaNova USA, Inc. | 2008-12-19 |
| UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S050) | Therakos Development Limited | 2008-12-19 |
| EPIC HF CRT-D SYSTEM (P030054/S111) | ABBOTT MEDICAL | 2008-12-19 |
| VNS THERAPY SYSTEM (P970003/S103) | LivaNova USA, Inc. | 2008-12-19 |
| EXOGEN BONE HEALING SYSTEM 2000 ,3000 (P900009/S021) | Bioventus, LLC | 2008-12-19 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S026) | W. L. Gore & Associates, Inc. | 2008-12-19 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT (P020018/S030) | Cook, Inc. | 2008-12-19 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S013) | DePuy Orthopaedics, Inc. | 2008-12-19 |
| CADENCE FAMILY OF ICDS (P910023/S189) | ABBOTT MEDICAL | 2008-12-18 |
| ATLAS II HF, ATLAS+ HF, ATLAS II+ HF, EPIC HF, EPIC II HF, EPIC+ HF, EPIC II+ HF, PROMOTE (P030054/S104) | ABBOTT MEDICAL | 2008-12-18 |
| CONTACT RENEWAL (P010012/S195) | Boston Scientific Corp | 2008-12-18 |
| TELIGEN ICDS (P960040/S185) | Boston Scientific | 2008-12-18 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S011) | Smith & Nephew, Inc. | 2008-12-18 |
| CONFIENT/TELIGEN/VITALITY (P960040/S184) | Boston Scientific | 2008-12-18 |
| COGNIS CRT-DS (P010012/S197) | Boston Scientific Corp | 2008-12-18 |
| BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S009) | Smith & Nephew, Inc. | 2008-12-18 |
| RENEWAL 3/LIVIAN/COGNIS (P010012/S196) | Boston Scientific Corp | 2008-12-18 |
| EXOGEN 4000+BONE HEALING SYSTEM (P900009/S029) | Bioventus, LLC | 2008-12-18 |
| PRIZM2/VITALITY (P960040/S183) | Boston Scientific | 2008-12-18 |
| CARPENTIER-EDWARDS BIOPROSTHESIS & BIOPROSTHETIC VALVED CONDUIT (P870056/S031) | Edwards Lifesciences, LLC | 2008-12-17 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S006) | LeMaitre Vascular, Inc. | 2008-12-17 |
| DUETT PRO SEALING DEVICE, MODEL 1010 (P990037/S028) | Vascular Solutions, Inc. | 2008-12-17 |
| MARQUIS/MAXIMO& MAXIMO II IPG/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/ONYX/VIRTUOSO FAMILY OF ICDS/SECURA ICD (P980016/S167) | Medtronic Cardiac Rhythm Disease Management | 2008-12-17 |
| KAPPA 600/700/650/800/900/ENPULSE/ENRHYTHM/SIGMA IPG/MEDTRONIC 350/ADAPTA/VERSA/SENSIA/RELIA/AT500 (P980035/S122) | Medtronic, Inc. | 2008-12-17 |
| AXSYM HBSAG, AXSYM HBSAG CONFIRMATORY AND AXSYM HBSAG CONTROLS (P050049/S003) | Abbott Laboratories, Inc. | 2008-12-17 |
| INSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-D (P010031/S134) | Medtronic Cardiac Rhythm Disease Management | 2008-12-17 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S030) | Edwards Lifesciences, LLC | 2008-12-17 |
| PRODIGY IPG (P890003/S158) | Medtronic, Inc. | 2008-12-17 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S052) | Edwards Lifesciences, LLC | 2008-12-17 |
| KAPPA 400 DR/SR IPG (P970012/S047) | Medtronic, Inc. | 2008-12-17 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S018) | Edwards Lifesciences, LLC | 2008-12-17 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S019) | Edwards Lifesciences, LLC | 2008-12-17 |
| INSYNC III CRT-P & INSYNC CRT-P (P010015/S057) | Medtronic, Inc. | 2008-12-17 |
| PARADIGM REAL-TIME INSULIN PUMPS & GUARDIAN REAL-TIME GLUCOSE MONITOR (P980022/S037) | Medtronic Minimed | 2008-12-16 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS (P010052/S005) | Siemens Healthcare Diagnostics Products, Ltd. | 2008-12-16 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S196) | ABBOTT MEDICAL | 2008-12-16 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM (P010053/S004) | Siemens Healthcare Diagnostics Products, Ltd. | 2008-12-16 |
| WALLSTENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S026) | Boston Scientific Corp | 2008-12-16 |
| IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC (P010051/S005) | Siemens Healthcare Diagnostics Products, Ltd. | 2008-12-16 |
| NEXGEN LEGACY KNEE ¿ POSTERIOR STABILIZED (LPS), LPS-FLEX MOBILE BEARING KNEE (P060037/S003) | Zimmer, Inc. | 2008-12-16 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S042) | Medtronic Minimed | 2008-12-16 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S007) | Boston Scientific Corp | 2008-12-16 |
| IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY (P010050/S006) | Siemens Healthcare Diagnostics Products, Ltd. | 2008-12-16 |
| TAXUS EXPRESS2 /TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P030025/S061) | Boston Scientific Corp | 2008-12-16 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S015) | Boston Scientific Corporation | 2008-12-16 |
| ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S025) | Medtronic, Inc. | 2008-12-16 |
| DUOVISC VISCOELASTIC SYSTEM & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S036) | Alcon Laboratories | 2008-12-15 |
| DRIVER CORONARY STENT SYSTEMS (P030009/S029) | Medtronic, Ireland | 2008-12-15 |