| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S026) | Edwards Lifesciences, LLC | 2011-01-20 |
| CERVISTA HPV HR TEST (P080014/S006) | Hologic, Inc. | 2011-01-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S114) | Boston Scientific Corp | 2011-01-20 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S075) | Edwards Lifesciences, LLC | 2011-01-20 |
| SPINAL CORD STIMULATION SYSTEMS (P840001/S175) | Medtronic Neuromodulation | 2011-01-20 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S013) | Carbon Medical Technologies, Inc. | 2011-01-20 |
| CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S038) | Edwards Lifesciences, LLC | 2011-01-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S067) | Boston Scientific Scimed, Inc. | 2011-01-19 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S070) | Boston Scientific Scimed, Inc. | 2011-01-19 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S053) | Medtronic, Ireland | 2011-01-19 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S004) | Medtronic Vascular | 2011-01-19 |
| SEPRAFILM ADHESION BARRIER (P950034/S037) | Baxter Healthcare Corporation | 2011-01-19 |
| VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S271) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| CONTAK RENEWAL TR (P030005/S072) | Guidant Corp. | 2011-01-19 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S029) | Gynecare, Inc. | 2011-01-19 |
| CONTAK RENEWAL 3/LIVIAN/COGNIS (P010012/S262) | Boston Scientific Corp | 2011-01-19 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S064) | Boston Scientific Corp | 2011-01-19 |
| PRIZM HE/3/VITALITY/2/AVT/CONFIENT/TELIGEN (P960040/S240) | Boston Scientific | 2011-01-19 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S226) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S272) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| TAXUS EXPRESS EXPRESS ATOM STENT (P030025/S092) | Boston Scientific Corp | 2011-01-19 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S227) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S022) | Abbott Laboratories | 2011-01-14 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S006) | Abbott Laboratories | 2011-01-14 |
| ON-X ASCENDING AORTIC PROSTHESIS (P000037/S018) | On-X Life Technologies, Inc. | 2011-01-14 |
| ARCHITECT CORE (P080023/S004) | Abbott Laboratories | 2011-01-14 |
| TAXUS LIBERTE MONORAIL & OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S063) | Boston Scientific Corp | 2011-01-14 |
| ACCENT PACERS AND ANTHEM RF CRT-P DEVICES (P030035/S076) | ABBOTT MEDICAL | 2011-01-14 |
| ETI-MAX 3000 ANALYZER (P990042/S008) | DiaSorin, Inc. | 2011-01-14 |
| ACCENT PACERS AND ANTHEM RF CRT-P DEVICES (P880086/S196) | ABBOTT MEDICAL | 2011-01-14 |
| VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM (P040016/S066) | Boston Scientific Scimed, Inc. | 2011-01-14 |
| PRODISC-L TOTAL DISC REPLACEMENT (P050010/S007) | Centinel Spine, LLC | 2011-01-14 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S045) | Abbott Vascular, Inc. | 2011-01-14 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S003) | Medtronic Vascular | 2011-01-14 |
| ARCHITECT CORE-M (P060035/S004) | Abbott Laboratories | 2011-01-14 |
| VENTAK AV/VENTAK PRIZM DR/VR/VITALITY ICDS (P960040/S239) | Boston Scientific | 2011-01-14 |
| SYNCHROMED & SYNCHROMED EL IMPLANTABLE PROGRAMMABLE INFUSION PUMPS (P860004/S129) | Medtronic, Inc. | 2011-01-14 |
| EXPRESS/EXPRESS2 MONORAIL & OTW CORONARY STENT SYSTEM (P020009/S069) | Boston Scientific Scimed, Inc. | 2011-01-14 |
| PRODISC-C TOTAL DISC REPLACEMENT (P070001/S004) | Centinel Spine, LLC | 2011-01-14 |
| ARCHITECT AUSAB (P050051/S008) | Abbott Laboratories, Inc. | 2011-01-14 |
| ARCHITECT ANTI-HCV (P050042/S008) | Abbott Laboratories, Inc. | 2011-01-14 |
| FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028) | Cook Medical Incorporated | 2011-01-14 |
| CONTAK CD & EASYTRAK CRT-D SYSTEM (P010012/S261) | Boston Scientific Corp | 2011-01-14 |
| ARCHITECT FREE PSA (P980007/S015) | Abbott Laboratories | 2011-01-13 |
| CONCERTO II/CONSULTA /MAXIMO II CRT-DS (P010031/S225) | Medtronic Cardiac Rhythm Disease Management | 2011-01-13 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S068) | Boston Scientific Scimed, Inc. | 2011-01-13 |
| CORMET HIP RESURFACING SYSTEM (P050016/S007) | Corin USA | 2011-01-13 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S065) | Boston Scientific Scimed, Inc. | 2011-01-13 |
| STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S030) | Starr Surgical Co. | 2011-01-13 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S062) | Boston Scientific Corp | 2011-01-13 |
| SECURA DRVR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S270) | Medtronic Cardiac Rhythm Disease Management | 2011-01-13 |
| ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S014) | Medtronic, Inc. | 2011-01-13 |
| ARCHITECT TOTAL PSA (P910007/S024) | Abbott Laboratories | 2011-01-13 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S018) | Boston Scientific Corp | 2011-01-13 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S030) | W. L. Gore & Associates, Inc. | 2011-01-13 |
| EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM (P090003/S008) | Boston Scientific Corporation | 2011-01-13 |
| MEDTRONIC ATTAIN STARFIX MODEL 4195 (P060039/S016) | Medtronic, Inc. | 2011-01-13 |
| CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S091) | Medtronic Minimed | 2011-01-12 |
| AUTODELFIA XPRESS HAFP TEST SYSTEM (P970037/S003) | Revvity, Inc. | 2011-01-12 |
| PHYSIO-STIM/SPINAL-STIM (P850007/S030) | Orthofix, Inc. | 2011-01-12 |
| SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S174) | Medtronic Neuromodulation | 2011-01-12 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S113) | Boston Scientific Corp | 2011-01-12 |
| CERVICAL-STIM (P030034/S004) | Orthofix, Inc. | 2011-01-12 |
| THERAPY ABLATION CATHETER (P040014/S015) | Irvine Biomedical, Inc. | 2011-01-11 |
| INTERSTIM THERAPY SYSTEM (P970004/S098) | Medtronic Neuromodulation | 2011-01-11 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S015) | Irvine Biomedical, Inc. | 2011-01-11 |
| DURASOFT 3 (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR (P830037/S051) | Alcon Laboratories, Inc. | 2011-01-11 |
| THERAPY DUAL 8 ABLATION CATHETER (P040042/S020) | Irvine Biomedical,Inc.(Ibi) | 2011-01-11 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S021) | Zoll Manufacturing Corporation | 2011-01-10 |
| LCS TOTAL KNEE SYSTEM (P830055/S117) | Depuy, Inc. | 2011-01-10 |
| CVS-300 EXCIMER LASER SYSTEM (P910001/S034) | Spectranetics Corp. | 2011-01-10 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S004) | Abbott Molecular, Inc. | 2011-01-10 |
| INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S224) | Medtronic Cardiac Rhythm Disease Management | 2011-01-07 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S017) | Boston Scientific Corporation | 2011-01-07 |
| UROLOGIX TARGIS SYSTEM (P970008/S053) | Urologix, LLC | 2011-01-07 |
| SPRINT QUATTRO (P920015/S072) | Medtronic, Inc. | 2011-01-07 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S028) | Biomet Manufacturing Corp | 2011-01-07 |
| INTERSTIM/INTERSTIM II/INTERSTIM LEAD KIT PERCUTANEOUS NON-TINED/INTERSTIM TINED LEAD KIT (P970004/S103) | Medtronic Neuromodulation | 2011-01-07 |
| LEAD KIT FOR DEEP BRAIN STIMULATION/QUADRIPOLAR EXTENSION KIT FOR DEEP BRAIN STIMULATION (P960009/S105) | Medtronic, Inc. | 2011-01-07 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER (P900056/S101) | Boston Scientific Corp | 2011-01-07 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S005) | Boston Scientific Corp | 2011-01-07 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S055) | Boston Scientific Scimed, Inc. | 2011-01-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S087) | Boston Scientific Corp | 2011-01-07 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S033) | St Jude Medical | 2011-01-07 |
| GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S269) | Medtronic Cardiac Rhythm Disease Management | 2011-01-07 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S048) | Boston Scientific Corp | 2011-01-07 |
| MERLIN 3650 PROGRAMMER (P030054/S179) | ABBOTT MEDICAL | 2011-01-07 |
| SYNCHROMED II (P860004/S145) | Medtronic, Inc. | 2011-01-07 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S023) | Boston Scientific Scimed, Inc. | 2011-01-07 |
| FLEXTOME CUTTING BALLOON (P950020/S040) | Boston Scientific Corp | 2011-01-07 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S033) | Hologic, Inc. | 2011-01-07 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S011) | Boston Scientific Corp | 2011-01-07 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S027) | Abbott Vascular Devices | 2011-01-07 |
| ITREL 3/SOLETRA/SYNERGY/SYNERGY VERSITREL/OCTAPOLAR EXTENSION KIT (IN-LINE CONNECTOR) FOR NEUROSTIMULATION (P840001/S173) | Medtronic Neuromodulation | 2011-01-07 |
| APLIGRAF (P950032/S061) | Organogenesis, Inc. | 2011-01-07 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S199) | Medtronic, Inc. | 2011-01-07 |
| DEMA IPGS (P990001/S081) | Medtronic, Inc. | 2011-01-07 |
| KAPPA 400 DR/SR IPGS (P970012/S080) | Medtronic, Inc. | 2011-01-07 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S106) | Medtronic, Inc. | 2011-01-07 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S090) | Medtronic Minimed | 2011-01-07 |