| THINLINE II, STEROX, FINELINE II STEROX AND FINELINE II STEROX EZ (P960004/S048) | Boston Scientific | 2011-03-24 |
| CONCERTO II ICD/CONSULTA/MAXIMO II CRT-DS (P010031/S237) | Medtronic Cardiac Rhythm Disease Management | 2011-03-24 |
| ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S204) | Medtronic, Inc. | 2011-03-24 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM IFU (P050007/S028) | Abbott Vascular Devices | 2011-03-24 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S005) | Medtronic Cryocath, LP | 2011-03-24 |
| PRESTIGE CERVICAL DISC (P060018/S002) | Medtronic Sofamor Danek, Inc. | 2011-03-24 |
| BIOFINITY CONTACT LENSES (P080011/S004) | CooperVision, Inc. | 2011-03-23 |
| ABBOTT ARCHITECT AUSAB (P050051/S010) | Abbott Laboratories, Inc. | 2011-03-23 |
| CONSULTA & SYNCRA CRT-PS IMPLANTABLE PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION (P010015/S084) | Medtronic, Inc. | 2011-03-22 |
| SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS (P980016/S240) | Medtronic Cardiac Rhythm Disease Management | 2011-03-22 |
| SYNCHROMED II INFUSION PUMP (P860004/S148) | Medtronic, Inc. | 2011-03-22 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S017) | Roche Molecular Systems, Inc. | 2011-03-22 |
| ENRHYTHM (P980035/S197) | Medtronic, Inc. | 2011-03-22 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S086) | Medtronic, Inc. | 2011-03-22 |
| CONCERTO II, CONSULTA AND MAXIMO II (P010031/S222) | Medtronic Cardiac Rhythm Disease Management | 2011-03-22 |
| CARELINK MONITOR MODELS 2490G/2491DDMA (P890003/S189) | Medtronic, Inc. | 2011-03-22 |
| REPLY/ESPRIT SR/DR PACERS (P950029/S056) | MicroPort CRM USA, Inc. | 2011-03-22 |
| ADAPTA/VERSA/SENSIA/RELIA IPG IMPLANTABLE PULSE GENERATOR (P980035/S147) | Medtronic, Inc. | 2011-03-22 |
| GEL-ONE (P080020) | Seikagaku Corp. | 2011-03-22 |
| VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES (P990001/S080) | Medtronic, Inc. | 2011-03-22 |
| DEMA IPG/C & T SERIES IPGS (P990001/S068) | Medtronic, Inc. | 2011-03-22 |
| MAXIMO II, SECURA AND VIRTUOSO II (P980016/S268) | Medtronic Cardiac Rhythm Disease Management | 2011-03-22 |
| KAPPA 400 DR/SR IPG (P970012/S068) | Medtronic, Inc. | 2011-03-22 |
| ARCHITECT AUSAB (P050051/S009) | Abbott Laboratories, Inc. | 2011-03-22 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S168) | Medtronic, Inc. | 2011-03-22 |
| AMPLICOR HCV TEST V2.0/COBAS AMPLICOR HCV TEST V2.0 (P000010/S020) | Roche Molecular Systems, Inc. | 2011-03-22 |
| CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S198) | Medtronic Cardiac Rhythm Disease Management | 2011-03-22 |
| CARELINK MONITOR SYSTEM (P890003/S178) | Medtronic, Inc. | 2011-03-22 |
| CARELINK DDMA SOFTWARE AND CARELINK MONITOR (P890003/S192) | Medtronic, Inc. | 2011-03-22 |
| ARCHITECT CORE-M (P060035/S006) | Abbott Laboratories | 2011-03-22 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S007) | Abbott Laboratories | 2011-03-22 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S029) | Roche Molecular Systems, Inc. | 2011-03-22 |
| ARCHITECT ANTI-HCV (P050042/S010) | Abbott Laboratories, Inc. | 2011-03-22 |
| UROVYSION BLADDER CANCER KIT (P030052/S004) | Abbott Molecular | 2011-03-22 |
| ABBOTT ARCHITECT TOTAL PSA (P910007/S019) | Abbott Laboratories | 2011-03-22 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S016) | Roche Molecular Systems, Inc. | 2011-03-22 |
| ARCHITECT CORE (P080023/S006) | Abbott Laboratories | 2011-03-22 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S070) | Boston Scientific Scimed, Inc. | 2011-03-18 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S060) | W. L. Gore & Associates, Inc. | 2011-03-18 |
| MARQUIS/MAXIMO (P980016/S283) | Medtronic Cardiac Rhythm Disease Management | 2011-03-18 |
| TALENT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P070007/S030) | Medtronic Vascular | 2011-03-18 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S007) | Medtronic Vascular | 2011-03-18 |
| MEDTRONIC REVO MRI PACEMAKER (P090013/S001) | Medtronic, Inc. | 2011-03-18 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S059) | Abbott Vascular, Inc. | 2011-03-18 |
| MULTI-LINK ZETA RX CORONARY STENT SYSTEM (P970020/S061) | Abbott Vascular, Inc. | 2011-03-18 |
| ORTHOVISC (P030019/S017) | Anika Therapeutics, Inc. | 2011-03-18 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S005) | Medtronic Vascular | 2011-03-18 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S010) | Boston Scientific Corporation | 2011-03-18 |
| SYNVISC & SYNVISC-ONE (P940015/S020) | Sanofi Genzyme Corp. | 2011-03-18 |
| MULTI-LINK VISION/MINI VISION/8TM/8TMLL/8TM SV CORONARY STENT SYSTEM (P020047/S031) | Abbott Vascular | 2011-03-18 |
| MULTI-LINK VISION/MINI VISION/MULTI-LINK 8TM/8TM LL/8TM SV CORONARY STENT SYSTEMS (P020047/S030) | Abbott Vascular | 2011-03-18 |
| KAPPA 400 (P970012/S083) | Medtronic, Inc. | 2011-03-18 |
| 350 SERIES/ADAPTA/ENPULSE (P980035/S205) | Medtronic, Inc. | 2011-03-18 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S006) | Medtronic Vascular | 2011-03-18 |
| PRODIGY IPG (P890003/S215) | Medtronic, Inc. | 2011-03-17 |
| STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION 2/SCORPION 2M ABLATION CATHETERS AND THE TEMPLINK/TEMPLINK M EXTENSION (P000020/S014) | Boston Scientific Corp | 2011-03-17 |
| ACTIVA SC INS/SOLETRA INS/KINETRA INS/POCKET ADAPTORS (P960009/S111) | Medtronic, Inc. | 2011-03-17 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICDS (P980016/S281) | Medtronic Cardiac Rhythm Disease Management | 2011-03-17 |
| ITREL 3 INS/SYNERGY FAMILY INS/POCKET ADAPTORS (P840001/S181) | Medtronic Neuromodulation | 2011-03-17 |
| INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D (P010031/S238) | Medtronic Cardiac Rhythm Disease Management | 2011-03-17 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S020) | Bard Peripheral Vascular, Inc. | 2011-03-17 |
| SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS (P980016/S284) | Medtronic Cardiac Rhythm Disease Management | 2011-03-17 |
| INTERSTIM INS (P970004/S107) | Medtronic Neuromodulation | 2011-03-17 |
| REVO MRI IPG (P090013/S002) | Medtronic, Inc. | 2011-03-17 |
| MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER (P890003/S210) | Medtronic, Inc. | 2011-03-17 |
| FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH) (P050043/S004) | Morris Innovative Research, Inc. | 2011-03-17 |
| MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S011) | Mentor Corp. | 2011-03-17 |
| MEDTRONIC CARELINK REMOTE HOME MONITOR (P890003/S195) | Medtronic, Inc. | 2011-03-17 |
| ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S206) | Medtronic, Inc. | 2011-03-17 |
| CONCERTO/II ICD/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S236) | Medtronic Cardiac Rhythm Disease Management | 2011-03-17 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S034) | Boston Scientific Corp | 2011-03-17 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S059) | W. L. Gore & Associates, Inc. | 2011-03-16 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S005) | Medtronic Vascular | 2011-03-16 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S038) | W. L. Gore & Associates, Inc. | 2011-03-16 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S031) | Baxter Healthcare Corp | 2011-03-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S020) | Smith & Nephew, Inc. | 2011-03-16 |
| XCEL TORIC (METHAFILCON A) SOFT CONTACT LENS (P850079/S049) | CooperVision, Inc. | 2011-03-16 |
| CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES (P010019/S020) | Alcon Laboratories, Inc. | 2011-03-16 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S029) | Intera Oncology | 2011-03-15 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S030) | Intera Oncology | 2011-03-15 |
| MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS (P840001/S102) | Medtronic Neuromodulation | 2011-03-15 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S028) | Intera Oncology | 2011-03-15 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025) | Medtronic Neuromodulation | 2011-03-14 |
| ADVIA CENTAUR ANTI-HBS ASSAY (P030029/S012) | Siemens Healthcare Diagnostics | 2011-03-14 |
| LCS COMPLETE TOTAL KNEE SYSTEM (P830055/S115) | Depuy, Inc. | 2011-03-11 |
| DIMENSION FPSA FLEX REAGENT CARTRIDGE (P000021/S018) | Siemens Healthcare Diagnostics | 2011-03-11 |
| SPINAL-STIM SPINAL FUSION SYSTEM (P850007/S031) | Orthofix, Inc. | 2011-03-11 |
| CERVICAL-STIM CERVICAL FUSION SYSTEM (P030034/S005) | Orthofix, Inc. | 2011-03-11 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S068) | Boston Scientific Corp | 2011-03-11 |
| ACRYSOF INTRAOCULAR LENS (IOL) (P930014/S023) | Alcon Laboratories, Inc. | 2011-03-11 |
| DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE (P020027/S013) | Siemens Healthcare Diagnostics | 2011-03-11 |
| QUICK-CLOSE VASCULAR SUTURING SYSTEM (P080029/S001) | Cardiva Medical, Inc. | 2011-03-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S023) | Ortho-Clinical Diagnostics, Inc. | 2011-03-10 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S036) | Cordis US Corporation | 2011-03-10 |
| SILIKON 1000 (P950008/S008) | Alcon | 2011-03-10 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S047) | Thoratec Laboratories Corp. | 2011-03-10 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S033) | Abbott Laboratories | 2011-03-10 |
| VISTAKON (ETAFILCON A) CONTACT LENSES (N18033/S048) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-03-10 |
| SYNCHROMED PROGRAMMABLE DRUG PUMPS (P860004/S146) | Medtronic, Inc. | 2011-03-09 |
| ACRYSOF IQ RESTOR INTRAOCULAR LENSES (P040020/S030) | Alcon Research, Ltd. | 2011-03-09 |