| MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC ICDS (P980016/S180) | Medtronic Cardiac Rhythm Disease Management | 2009-10-01 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S004) | Bard Peripheral Vascular, Inc. | 2009-10-01 |
| ACRYSOF RESTOR MULTIFOCAL INTRACULAR LENSES (P040020/S020) | Alcon Research, Ltd. | 2009-10-01 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S003) | Exactech, Inc. | 2009-09-30 |
| TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S019) | Boston Scientific Corp | 2009-09-30 |
| LIVEWIRE TC & SAFIRE CARDIAC ABLATION SYSTEMS (P960016/S024) | St Jude Medical | 2009-09-30 |
| FLEXTOME CUTTING BALLOON OTW PTCA CATHETER (P950020/S034) | Boston Scientific Corp | 2009-09-30 |
| QUANTUM MAVERICK PTCA CATHETER/MAVERICK OTW PTCA CATHETER (P860019/S240) | Scimed Life Systems, Inc. | 2009-09-30 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S064) | Boston Scientific Corp | 2009-09-30 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S050) | Boston Scientific Scimed, Inc. | 2009-09-30 |
| LIBERTE' CORONARY STENT SYSTEM (P040016/S036) | Boston Scientific Scimed, Inc. | 2009-09-30 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S028) | Medtronic, Inc. | 2009-09-29 |
| DURATA, RIATA, RIATA ST, AND RIATA ST OPTIM FAMILY OF LEADS (P950022/S063) | ABBOTT MEDICAL | 2009-09-29 |
| HANCOCK II BIOPROSTHESIS (P980043/S021) | Medtronic, Inc. | 2009-09-29 |
| CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S001) | Boston Scientific Corp | 2009-09-25 |
| TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS (P960013/S051) | ABBOTT MEDICAL | 2009-09-25 |
| ADAPTA, VERSA, SENSIA AND RELIA IPG FAMILIES (P980035/S140) | Medtronic, Inc. | 2009-09-25 |
| RIATA/RIATA ST & DURATA FAMILIES OF LEADS (P950022/S064) | ABBOTT MEDICAL | 2009-09-25 |
| QUICKSITE/QUICKFLEX FAMILIES OF LEADS (P030054/S132) | ABBOTT MEDICAL | 2009-09-25 |
| VERIFLEX FOR LIBERTE BARE METAL STENTS (P040016/S037) | Boston Scientific Scimed, Inc. | 2009-09-25 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S010) | Abbott Laboratories | 2009-09-25 |
| SUPARTZ (P980044/S010) | Seikagaku Corp. | 2009-09-25 |
| AESCULA FAMILY OF LEFT HEART LEADS (P030035/S058) | ABBOTT MEDICAL | 2009-09-25 |
| ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS (P030049/S002) | Siemens Healthcare Diagnostics | 2009-09-25 |
| MEDTRONIC CARELINK HOME MONITOR MODEL 2490 (P890003/S173) | Medtronic, Inc. | 2009-09-25 |
| PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFELX OPTIM FAMILIES OF LEADS (P960030/S027) | ABBOTT MEDICAL | 2009-09-25 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S024) | W. L. Gore & Associates, Inc. | 2009-09-23 |
| DEXCOM SEVEN PLUS SYSTEM (P050012/S020) | Dexcom, Inc. | 2009-09-23 |
| SONATATI100 IMPLANT (P000025/S043) | Med-El Corp. | 2009-09-23 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S017) | W. L. Gore & Associates, Inc. | 2009-09-23 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT (P020052/S005) | St Jude Medical | 2009-09-22 |
| APEX PTCA BALLOON DILITATION CATHETER (P860019/S237) | Scimed Life Systems, Inc. | 2009-09-22 |
| RELIANCE LEADS (P910073/S079) | Boston Scientific | 2009-09-22 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S019) | Abbott Laboratories | 2009-09-21 |
| CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS (P860057/S059) | Edwards Lifesciences, LLC | 2009-09-18 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S067) | Cordis Corp. | 2009-09-18 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S009) | Natus Medical Incorporated | 2009-09-18 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S112) | Medtronic, Inc. | 2009-09-18 |
| CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II (P010031/S163) | Medtronic Cardiac Rhythm Disease Management | 2009-09-18 |
| VIRTUOSO/VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S202) | Medtronic Cardiac Rhythm Disease Management | 2009-09-18 |
| STARCLOSURE SE VASCULAR CLOSURE SYSTEM (P050007/S021) | Abbott Vascular Devices | 2009-09-18 |
| RAPTORRAIL RX SDS, 2.25MM CYPHER STENT (P020026/S017) | Cordis Corp. | 2009-09-18 |
| MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW (P860019/S234) | Scimed Life Systems, Inc. | 2009-09-18 |
| TENDRIL 1888 LEADS (P960013/S050) | ABBOTT MEDICAL | 2009-09-17 |
| DEXCOM SEVEN PLUS SYSTEM (P050012/S019) | Dexcom, Inc. | 2009-09-17 |
| GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE) (P040037/S023) | W. L. Gore & Associates, Inc. | 2009-09-17 |
| TENDRIL 1888 LEAD (P960013/S049) | ABBOTT MEDICAL | 2009-09-17 |
| ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES (P040021/S010) | ABBOTT MEDICAL | 2009-09-16 |
| COGNIS PULSE GENERATOR (P010012/S218) | Boston Scientific Corp | 2009-09-16 |
| POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM (P040002/S025) | Endologix, LLC | 2009-09-16 |
| SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS (P840001/S140) | Medtronic Neuromodulation | 2009-09-16 |
| DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS (P960009/S069) | Medtronic, Inc. | 2009-09-16 |
| TELIGEN (P960040/S203) | Boston Scientific | 2009-09-16 |
| LCS TOTAL KNEE SYSTEM (P830055/S111) | Depuy, Inc. | 2009-09-16 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S054) | Therakos Development Limited | 2009-09-15 |
| ENDEAVOR ZOTAROLIMUS/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S041) | Medtronic, Inc. | 2009-09-15 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S022) | Hologic, Inc. | 2009-09-15 |
| ADVIA CENTAUR AHBS ASSAY (P030029/S008) | Siemens Healthcare Diagnostics | 2009-09-15 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S035) | Medtronic, Ireland | 2009-09-15 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S066) | Cordis Corp. | 2009-09-14 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S020) | Abbott Vascular Devices | 2009-09-14 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S014) | Abbott Vascular, Inc. | 2009-09-11 |
| REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM (P030022/S013) | Smith & Nephew, Inc. | 2009-09-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S010) | Ortho-Clinical Diagnostics | 2009-09-11 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S015) | Coloplast Corp. | 2009-09-11 |
| CERVICAL-STIM (P030034/S003) | Orthofix, Inc. | 2009-09-11 |
| PHYSIO-STIM AND SPINAL STIM (P850007/S029) | Orthofix, Inc. | 2009-09-11 |
| SYNCHROMED II INFUSION PUMP (P860004/S111) | Medtronic, Inc. | 2009-09-09 |
| APEX PTCA BALLOON DILATATION CATHETER (P860019/S238) | Scimed Life Systems, Inc. | 2009-09-08 |
| REPLY DR/SR PACEMAKERS (P950029/S045) | MicroPort CRM USA, Inc. | 2009-09-04 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S005) | Bard Peripheral Vascular | 2009-09-04 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S009) | Allergan | 2009-09-04 |
| SYNCHROMED II IMPLANTABLE INFUSION SYSTEM (P860004/S108) | Medtronic, Inc. | 2009-09-04 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013) | Integra LifeSciences Corporation | 2009-09-04 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S041) | Med-El Corp. | 2009-09-03 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S007) | Alcon Laboratories | 2009-09-03 |
| INSYNC II/III MARQUIS ICDS/INSYNC II/III PROTECT ICDS/INTRINSIC ICD (P010031/S162) | Medtronic Cardiac Rhythm Disease Management | 2009-09-03 |
| APLIGRAF (P950032/S053) | Organogenesis, Inc. | 2009-09-03 |
| MARQUIS VR/DR ICD (P980016/S201) | Medtronic Cardiac Rhythm Disease Management | 2009-09-03 |
| ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S039) | Medtronic, Inc. | 2009-09-03 |
| COSEAL SURGICAL SEALANT DEVICE (P030039/S013) | Baxter Bio Science | 2009-09-03 |
| MODEL 3550-39 TITAN ANCHOR (P840001/S135) | Medtronic Neuromodulation | 2009-09-02 |
| PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM (P980052/S004) | Stryker Leibinger, GmbH & Co KG | 2009-09-02 |
| TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P070007/S011) | Medtronic Vascular | 2009-09-01 |
| TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P070027/S010) | Medtronic Vascular | 2009-09-01 |
| BARD LIFESTENT VASCULAR STENT SYSTEM (P070014/S003) | Bard Peripheral Vascular, Inc. | 2009-09-01 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S019) | Abbott Vascular Devices | 2009-09-01 |
| ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM (P990020/S035) | Medtronic Vascular | 2009-09-01 |
| TENDRIL ST LEAD MODEL 1882 LEADS (P960013/S048) | ABBOTT MEDICAL | 2009-08-28 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S011) | Irvine Biomedical, Inc. | 2009-08-28 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S048) | Cochlear Americas | 2009-08-28 |
| EMS-SWISS DOLORCLAST (P050004/S001) | Electro Medical Systems (Ems Sa) | 2009-08-28 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S004) | Corcym Canada Corp | 2009-08-28 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S012) | Integra LifeSciences Corporation | 2009-08-28 |
| THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S016) | Irvine Biomedical,Inc.(Ibi) | 2009-08-28 |
| TRILOGY AB ACETABULAR SYSTEM (P040048/S008) | Zimmer, Inc. | 2009-08-27 |
| UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH (P970008/S045) | Urologix, LLC | 2009-08-27 |
| WAVSTAT OPTICAL BIOPSY SYSTEM (P990050/S007) | Spectra Science | 2009-08-27 |
| CONCEPTUS ESSURE SYSTEM (P020014/S024) | Bayer Pharma AG | 2009-08-26 |
| NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P910031/S026) | Abbott Vascular Devices | 2009-08-26 |