| ABBOTT AXSYM HBSAG (P050049/S008) | Abbott Laboratories, Inc. | 2011-11-14 |
| RF CONTACTR, RF CONDUCTR, RF MARINR, RF MARINR 5FR AND RF ENHANCER II FAMILIES OF ABLATION CATHETERS (P930029/S034) | Medtronic, Inc. | 2011-11-14 |
| BELOTERO BALANCE (P090016) | Merz North America, Inc. | 2011-11-14 |
| VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY (P010021/S021) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY (P030026/S024) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| CORMET HIP RESURFACING SYSTEM (P050016/S008) | Corin USA | 2011-11-10 |
| THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 (P060019/S019) | Irvine Biomedical, Inc. | 2011-11-10 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S259) | Medtronic Cardiac Rhythm Disease Management | 2011-11-10 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S032) | Boston Scientific Corp | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY (P000014/S024) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| ACTIVA (P960009/S130) | Medtronic, Inc. | 2011-11-10 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S197) | Medtronic Neuromodulation | 2011-11-10 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S024) | W. L. Gore & Associates, Inc. | 2011-11-10 |
| TOP2A FISH PHARMDX KIT (P050045/S003) | Dako Denmark A/S | 2011-11-10 |
| SYNCHROMED II PUMP (P860004/S159) | Medtronic, Inc. | 2011-11-10 |
| MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S305) | Medtronic Cardiac Rhythm Disease Management | 2011-11-10 |
| BD FOCALPOINT SLIDE PROFILER (P950009/S013) | Bd Diagnostics | 2011-11-10 |
| SYNCHROMED FAMILY OF INFUSION SYSTEMS (P860004/S160) | Medtronic, Inc. | 2011-11-10 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S062) | W. L. Gore & Associates, Inc. | 2011-11-10 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S077) | ABBOTT MEDICAL | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY (P030024/S017) | Ortho-Clinical Diagnostics | 2011-11-10 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S014) | Neomend, Inc. | 2011-11-10 |
| THERAPY CARDIAC ABLATION SYSTEM (P040014/S018) | Irvine Biomedical, Inc. | 2011-11-10 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S023) | Irvine Biomedical,Inc.(Ibi) | 2011-11-10 |
| ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S131) | Medtronic, Inc. | 2011-11-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG ASSAY AND HBSAG CONFIRMATORY KIT (P000044/S028) | Ortho-Clinical Diagnostics, Inc. | 2011-11-10 |
| MEDTRONIC PROTECTA XT CRT-D D314TRM AND PROTECTA CRT-D D334 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P010031/S178) | Medtronic Cardiac Rhythm Disease Management | 2011-11-09 |
| MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS (P980016/S218) | Medtronic Cardiac Rhythm Disease Management | 2011-11-09 |
| INTERSTIM II INS (P080025/S004) | Medtronic Neuromodulation | 2011-11-09 |
| ACTIVA PC/RC INS & EXTERNAL NEUROSTIMULATOR (P960009/S115) | Medtronic, Inc. | 2011-11-09 |
| MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER (P890003/S181) | Medtronic, Inc. | 2011-11-09 |
| SYNCHROMED PUMP (P860004/S150) | Medtronic, Inc. | 2011-11-09 |
| INTERSTIM II INS (P970004/S112) | Medtronic Neuromodulation | 2011-11-09 |
| VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S139) | LivaNova USA, Inc. | 2011-11-09 |
| RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RETSOREADVANCED/EXTERNAL NEUROSTIMULAR INS (P840001/S184) | Medtronic Neuromodulation | 2011-11-09 |
| ARTISAN/VERISYSE PHAKIC IOL (P030028/S001) | Ophtec BV | 2011-11-09 |
| CLEARREAD DETECT (P000041/S010) | Riverain Medical Group | 2011-11-08 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S025) | W. L. Gore & Associates, Inc. | 2011-11-04 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S087) | Cochlear Americas | 2011-11-04 |
| TRILOGY AB ACETABULAR SYSTEM (P040048/S015) | Zimmer, Inc. | 2011-11-04 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S001) | DePuy Orthopaedics, Inc. | 2011-11-04 |
| ENDOLUMINAL PROSTHESIS (P040002/S034) | Endologix, LLC | 2011-11-04 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S045) | Best Vascular, Inc. | 2011-11-04 |
| MEDTRONIC 37085 EXTENSION (P960009/S128) | Medtronic, Inc. | 2011-11-03 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S037) | CooperSurgical, Inc. | 2011-11-03 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S246) | Medtronic, Inc. | 2011-11-03 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S022) | Alcon Research, Ltd. | 2011-11-03 |
| 7426 SOLETRA IMPLANTABLE NEUROSTIMULATOR (P960009/S129) | Medtronic, Inc. | 2011-11-03 |
| REVO MRI (P090013/S041) | Medtronic, Inc. | 2011-11-03 |
| GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS (P010032/S043) | ABBOTT MEDICAL | 2011-11-03 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV & HEALON 5 PRODUCTS (P810031/S041) | Johnson & Johnson Surgical Vision, Inc. | 2011-11-03 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECCTA/PROTECTA XT (P010031/S278) | Medtronic Cardiac Rhythm Disease Management | 2011-11-03 |
| RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S185) | Medtronic Neuromodulation | 2011-11-03 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S141) | Medtronic, Inc. | 2011-11-03 |
| MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S324) | Medtronic Cardiac Rhythm Disease Management | 2011-11-03 |
| PLASMAFLO OP-05W (A) (P820033/S008) | Asahi Kasei Medical Co., Ltd. | 2011-11-02 |
| CERVICAL-STIM (P030034/S006) | Orthofix, Inc. | 2011-11-02 |
| GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS (P010032/S039) | ABBOTT MEDICAL | 2011-11-02 |
| AIR OPTIX NIGHT & DAY AQUA (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S025) | Alcon Laboratories, Inc. | 2011-11-02 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S038) | Boston Scientific Corp | 2011-11-02 |
| PHYSIO-STIM & SPINAL-STIM (P850007/S032) | Orthofix, Inc. | 2011-11-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041) | Edwards Lifesciences, LLC | 2011-11-02 |
| ADAPTA/VERSA/SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR (P980035/S244) | Medtronic, Inc. | 2011-11-01 |
| FORTIFY AND VARIOUS FAMILIES OF CURRENT (P030054/S202) | ABBOTT MEDICAL | 2011-11-01 |
| TENDRIL STS 1988TC AND 2088TC (P960013/S066) | ABBOTT MEDICAL | 2011-11-01 |
| MELAFIND (P090012) | Strata Skin Sciences, Inc. | 2011-11-01 |
| VARIOUS FAMILIES OF PROMOTE AND UNIFY (P910023/S276) | ABBOTT MEDICAL | 2011-11-01 |
| Xience Skypoint Everolimus Eluting Coronary Stent System (P110019) | Abbott Vascular | 2011-11-01 |
| VERIFLEX (FORMERLY LIBERTE) CORONARY STENT SYSTEM (P040016/S080) | Boston Scientific Scimed, Inc. | 2011-10-31 |
| RADIESSE INJECTABLE IMPLANT (P050037/S024) | Merz North America, Inc. | 2011-10-31 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S055) | Alcon Laboratories, Inc. | 2011-10-31 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S081) | Boston Scientific Corp | 2011-10-31 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S081) | Boston Scientific Scimed, Inc. | 2011-10-31 |
| VNS THERAPY SYSTEM (P970003/S135) | LivaNova USA, Inc. | 2011-10-31 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S008) | Bard Peripheral Vascular, Inc. | 2011-10-31 |
| RADIESSE INJECTABLE IMPLANT (P050052/S027) | Merz North America, Inc. | 2011-10-31 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S026) | Boston Scientific Corp | 2011-10-31 |
| ENTRUST; INTRINSIC; MARQUIS; ONYX; SECURA; VARIOUS FAMILIES OF GEM, MAXIMO, PROTECTA, & VIRTUOSO (P980016/S321) | Medtronic Cardiac Rhythm Disease Management | 2011-10-31 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S080) | Boston Scientific Corp | 2011-10-31 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S036) | Alcon Research, Ltd. | 2011-10-31 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S021) | Bard Peripheral Vascular | 2011-10-31 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S079) | Boston Scientific Scimed, Inc. | 2011-10-31 |
| CONSULTA; MAXIMO II; & VARIOUS FAMILIES OF CONCERTO, INSYNC, & PROTECTA (P010031/S275) | Medtronic Cardiac Rhythm Disease Management | 2011-10-31 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S028) | Bard Peripheral Vascular, Inc. | 2011-10-31 |
| ESTEEM (P090018/S013) | Envoy Medical Corporation | 2011-10-28 |
| LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S026) | Alcon Laboratories, Inc. | 2011-10-28 |
| APTIMA HPV ASSAY (P100042) | Gen-Probe Incorporated | 2011-10-28 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S026) | W. L. Gore & Associates, Inc. | 2011-10-28 |
| XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S081) | Abbott Vascular, Inc. | 2011-10-28 |
| VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS (P020047/S040) | Abbott Vascular | 2011-10-28 |
| GENESIS & EON FAMILY OF NEUORSTIMULATION DEVICES (P010032/S041) | ABBOTT MEDICAL | 2011-10-28 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S025) | Boston Scientific Corp | 2011-10-28 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEMS (P860003/S062) | Therakos Development Limited | 2011-10-28 |
| MULTILINK ZETA & ULTRA CORONARY STENT SYSTEMS (P970020/S069) | Abbott Vascular, Inc. | 2011-10-28 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S026) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S043) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S066) | W. L. Gore & Associates, Inc. | 2011-10-27 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S023) | Bard Peripheral Vascular, Inc. | 2011-10-27 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY SYSTEM (P100023/S023) | Boston Scientific Corp | 2011-10-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S022) | W. L. Gore & Associates, Inc. | 2011-10-27 |