| THE HEART LASER CO2 TMR SYSTEM (P950015/S011) | Laser Engineering Heart, Inc. | 2009-03-08 |
| ATTAIN LV & CS (P010015/S061) | Medtronic, Inc. | 2009-03-06 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S016) | Medtronic, Inc. | 2009-03-06 |
| CAPSURE Z/CAPSURE Z/SP NOVUS & VITATRON IMPULSE & IMPLUSE II & VIATRON EXCELLENCE SS + (P850089/S061) | Medtronic Cardiac Rhythm Disease Management | 2009-03-06 |
| SELECTSECURE (P030036/S012) | Medtronic Cardiac Rhythm Disease Management | 2009-03-06 |
| VNS THERAPY SYSTEM (P970003/S106) | LivaNova USA, Inc. | 2009-03-06 |
| ADVIA CENTAUR PSA ASSAY (P950021/S010) | Siemens Healthcare Diagnostics | 2009-03-06 |
| CAPSURE FIX (P980016/S177) | Medtronic Cardiac Rhythm Disease Management | 2009-03-06 |
| SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE (P920015/S052) | Medtronic, Inc. | 2009-03-06 |
| ADVIA CENTAUR PSA & CPSA ASSAYS (P990055/S011) | Siemens Healthcare Diagnostics | 2009-03-06 |
| CAPSURE/CAPSURE SP/CAPSURE SP NOVUS/CAPSURE SENSE/VITATRON EXCELLENCE +/PS+/CRYSTALLINE (P830061/S045) | Medtronic Cardiac Rhythm Disease Management | 2009-03-06 |
| CAPSUREFIX & CAPSUREFIX NOVUS & VITATRON PIROUET S+ & VITATRON CRYSTALLINE ACTFIX (P930039/S030) | Medtronic, Inc. | 2009-03-06 |
| DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S089) | Medtronic Cardiac Rhythm Disease Management | 2009-03-06 |
| REPEL-CV BIORESORBABLE ADHESION BARRIER (P070005) | Pathfinder Cell Therapy, Inc. | 2009-03-06 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S009) | Abbott Laboratories | 2009-03-06 |
| RADIESSE INJECTABLE IMPLANT (P050037/S020) | Merz North America, Inc. | 2009-03-06 |
| RADIESSE INJECTABLE IMPLANT (P050052/S022) | Merz North America, Inc. | 2009-03-06 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S010) | Smith & Nephew, Inc. | 2009-03-06 |
| TRANSVENE CS/SVC LEAD (P980050/S040) | Medtronic, Inc. | 2009-03-06 |
| COAPTITE INJECTABLE IMPLANT (P040047/S014) | Merz North America, Inc. | 2009-03-06 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S081) | Boston Scientific Corp | 2009-03-06 |
| CAPSURE VDD-2 & BRILLIANT S+ (P890003/S163) | Medtronic, Inc. | 2009-03-06 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S078) | Advanced Bionics | 2009-03-05 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S039) | W. L. Gore & Associates, Inc. | 2009-03-05 |
| RESTYLANE INJECTABLE GELS (P040024/S035) | Q-Med AB | 2009-03-05 |
| ATS 3F AORTIC BIOPROSTHESIS MODEL 1000 (P060025/S003) | Medtronic, Inc. | 2009-03-05 |
| UROLOGIX TARGIS SYSTEM (P970008/S043) | Urologix, LLC | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| ABBOTT AXSYM AUSAB (P060003/S004) | Abbott Laboratories, Inc. | 2009-03-05 |
| STARFLEX SEPTAL OCCLUSION SYSTEM (P000049/S016) | Nmt Medical, Inc. | 2009-03-05 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S019) | W. L. Gore & Associates, Inc. | 2009-03-04 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S011) | DePuy Orthopaedics, Inc. | 2009-03-04 |
| ADVIA CENTAUR HBCIGM (P030040/S003) | Siemens Healthcare Diagnostics | 2009-03-04 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S032) | Medtronic, Inc. | 2009-03-04 |
| ADVIA CENTAUR HCV (P030056/S003) | Siemens Healthcare Diagnostics | 2009-03-04 |
| OVATIO CRT & SITUS OTW LV (P060027/S009) | MicroPort CRM USA, Inc. | 2009-03-04 |
| EXABLATE 2000 SYSTEM (P040003/S005) | Insightec, Ltd. | 2009-03-04 |
| DRIVER & MICRODRIVER CORONARY STENT SYSTEM (P030009/S033) | Medtronic, Ireland | 2009-03-04 |
| ADVIA CENTAUR HBSAG (P030049/S003) | Siemens Healthcare Diagnostics | 2009-03-04 |
| RESTYLANE AND PERLANE INJECTABLE GELS (P040024/S034) | Q-Med AB | 2009-03-04 |
| ADVIA CENTAUR HBCT (P040004/S003) | Siemens Healthcare Diagnostics | 2009-03-04 |
| ALLERGAN SALINE-FILLED BREAST IMPLANTS (P990074/S021) | Allergan | 2009-03-03 |
| ELECSYS FREE PSA IMMUNOASSAY, PSA CALSET & PSA CALCHECK (P000027/S005) | Roche Diagnostics Corp. | 2009-03-03 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE (P970055/S007) | Diasorin | 2009-03-03 |
| ADAPTA/VERSA/SENIA/RELIA IPG (P980035/S127) | Medtronic, Inc. | 2009-03-03 |
| BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE (P970054/S007) | Diasorin | 2009-03-03 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S004) | Bard Peripheral Vascular | 2009-03-03 |
| DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS (P960009/S062) | Medtronic, Inc. | 2009-03-02 |
| XIENCE V EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P070015/S012) | Abbott Vascular, Inc. | 2009-03-02 |
| SPINAL CORD FAMILY OF NEUROSTIMULATION LEADS (P840001/S129) | Medtronic Neuromodulation | 2009-03-02 |
| INTERSTIM FAMILY OF NEUROSTIMULATION LEADS (P970004/S070) | Medtronic Neuromodulation | 2009-03-02 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OTW & MULTI-EXCHANGE II (MX2) & RAPID EXCHANGE (RX) DELIVERY SYSTEM (P060033/S011) | Medtronic, Inc. | 2009-03-02 |
| RIATA ST OPTIM & DURATA LEADS (P950022/S058) | ABBOTT MEDICAL | 2009-02-27 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S026) | Alcon Research, Ltd. | 2009-02-27 |
| AESCULA FAMILY OF LEFT HEART LEADS (P030035/S054) | ABBOTT MEDICAL | 2009-02-27 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX (P060038/S002) | Corcym Canada Corp | 2009-02-27 |
| PASSIVE PLUS/ISOFLEX S&P/ISOFELX OPTIM FAMILIES OF LEADS (P960030/S025) | ABBOTT MEDICAL | 2009-02-27 |
| ATLAS II+ HF CRT-D & PROMOTE CRT-D (P030054/S116) | ABBOTT MEDICAL | 2009-02-27 |
| ALLERGAN NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S010) | Allergan | 2009-02-27 |
| LUMA CERVICAL IMAGING SYSTEM (P040028/S003) | Spectra Science | 2009-02-27 |
| QUICKSITE & QUICKFLEX FAMILIES OF LEADS (P030054/S115) | ABBOTT MEDICAL | 2009-02-27 |
| VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S038) | Alcon Laboratories | 2009-02-27 |
| TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS (P960013/S042) | ABBOTT MEDICAL | 2009-02-27 |
| RIATA/RIATA ST & DURATA FAMILIES OF LEADS (P950022/S057) | ABBOTT MEDICAL | 2009-02-27 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S029) | Boston Scientific Corp | 2009-02-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S041) | W. L. Gore & Associates, Inc. | 2009-02-26 |
| E-LUMINEXX VASCULAR STENT (P080007/S001) | Bard Peripheral Vascular, Inc. | 2009-02-26 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S015) | W. L. Gore & Associates, Inc. | 2009-02-26 |
| CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S018) | Bausch & Lomb, Inc. | 2009-02-26 |
| SYNVISC-ONE (P940015/S012) | Sanofi Genzyme Corp. | 2009-02-26 |
| CONCERTO CRT-D (P010031/S142) | Medtronic Cardiac Rhythm Disease Management | 2009-02-25 |
| RADIESSE INJECTABLE IMPLANT (P050052/S021) | Merz North America, Inc. | 2009-02-25 |
| RADIESSE INJECTABLE IMPLANT (P050037/S018) | Merz North America, Inc. | 2009-02-25 |
| SELECTSECURE LEAD (P030036/S009) | Medtronic Cardiac Rhythm Disease Management | 2009-02-25 |
| UROVYSION BLADDER CANCER KIT (P030052/S003) | Abbott Molecular | 2009-02-25 |
| ETI-EBK PLUS KIT (P990043/S011) | DiaSorin, Inc. | 2009-02-25 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S074) | Boston Scientific Corp | 2009-02-25 |
| RADIESSE INJECTABLE IMPLANT (P050037/S019) | Merz North America, Inc. | 2009-02-25 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S002) | Bio-Rad Laboratories, Inc. | 2009-02-25 |
| RADIESSE INJECTABLE IMPLANT (P050052/S020) | Merz North America, Inc. | 2009-02-25 |
| VIRTUOSO ICD (P980016/S176) | Medtronic Cardiac Rhythm Disease Management | 2009-02-25 |
| ETI-AB-EBK PLUS KIT (P990041/S010) | DiaSorin, Inc. | 2009-02-25 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S028) | Boston Scientific Corp | 2009-02-24 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S031) | Cook, Inc. | 2009-02-24 |
| MEDTRONIC CARELINK PROGRAMMER (P890003/S155) | Medtronic, Inc. | 2009-02-24 |
| VNS THERAPY PULSE MODEL 102 & PULSE DUO MODEL 102R GENERATOR (P970003/S105) | LivaNova USA, Inc. | 2009-02-23 |
| OVATIO CRT (P060027/S010) | MicroPort CRM USA, Inc. | 2009-02-23 |
| XACT CAROTID STENT SYSTEM (P040038/S017) | Abbott Vascular, Inc. | 2009-02-23 |
| REALIZE ADJUSTABLE GASTRIC BAND (P070009/S004) | Obtech Medical GmbH | 2009-02-23 |
| XACT CAROTID STENT SYSTEM (P040038/S014) | Abbott Vascular, Inc. | 2009-02-23 |
| OVATIO VR/DR (P980049/S045) | MicroPort CRM USA, Inc. | 2009-02-23 |
| SYMPHONY SR 2250, SYMPHONY DR 2550, RHAPSODY SR 2210, RHAPSODY DR 2510, RHAPSODY DR 2530, REPLY ST & REPLY DR PACEMAKERS (P950029/S040) | MicroPort CRM USA, Inc. | 2009-02-23 |
| INFUSE BONE GRAFT (P050053/S011) | Medtronic, Inc. | 2009-02-20 |
| INFUSE BONE GRAFT (P000054/S020) | Medtronic Sofamor Danek USA, Inc. | 2009-02-20 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX (P860057/S054) | Edwards Lifesciences, LLC | 2009-02-20 |
| POWERLINK SYSTEM (P040002/S023) | Endologix, LLC | 2009-02-20 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER (P040036/S008) | Biosense Webster, Inc. | 2009-02-20 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S002) | Bio-Rad Laboratories, Inc. | 2009-02-20 |
| NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER (P030031/S010) | Biosense Webster, Inc. | 2009-02-20 |
| INFUSE BONE GRAFT/LT-CAGE LUMBER TAPERED FUSION DEVICE (P000058/S031) | Medtronic Sofamor Danek USA, Inc. | 2009-02-20 |