| RENEWAL (P030005/S069) | Guidant Corp. | 2010-09-17 |
| COROX OTW/STRATOS LV/LV-T (P070008/S018) | Biotronik, Inc. | 2010-09-17 |
| VNS THERAPY PROGRAMMING SOFTWARE (P970003/S112) | LivaNova USA, Inc. | 2010-09-17 |
| VITALITY/PRIZM/CONFIENT/TELIGEN (P960040/S232) | Boston Scientific | 2010-09-17 |
| FREEZOR/FREEZOR XTRA SURGICAL/FREEZOR MAX SURGICAL CATHETERS AND CRYOCONSOLE (P020045/S034) | Medtronic Cryocath, LP | 2010-09-17 |
| VERSANT & APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S002) | Gen-Probe | 2010-09-17 |
| LIVIAN/RENEWAL/COGNIS (P010012/S252) | Boston Scientific Corp | 2010-09-17 |
| LEXOS/LUMOS ICDS (P000009/S041) | Biotronik, Inc. | 2010-09-17 |
| VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S004) | Gen-Probe | 2010-09-17 |
| LINOX SMART STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S038) | Biotronik, Inc. | 2010-09-17 |
| COMBI 40+ COCHLEAR SYSTEM (MAESTRO COCHLER IMPLANT SYSTEM) (P000025/S049) | Med-El Corp. | 2010-09-17 |
| TORIC LENS BENCH WITH RENISHAW GAUGE ACRYSOF TORIC & ACRYSOF IQ INTRAOCULAR LENSES (P930014/S043) | Alcon Laboratories, Inc. | 2010-09-17 |
| LUMAX ICDS/COROX OTW UP STEROID (P050023/S037) | Biotronik, Inc. | 2010-09-17 |
| COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL (P990013/S029) | Starr Surgical Co. | 2010-09-16 |
| SILICON UV-ABSORBING POSTERIOR CHAMBER IOL (P880091/S032) | Staar Surgical Co. | 2010-09-16 |
| RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR (P840001/S163) | Medtronic Neuromodulation | 2010-09-16 |
| BD FOCALPOINT GS IMAGING SYSTEM (P950009/S012) | Bd Diagnostics | 2010-09-16 |
| BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) (P010012/S230) | Boston Scientific Corp | 2010-09-16 |
| THINPREP IMAGING SYSTEM LABELING (P020002/S005) | Hologic, Inc. | 2010-09-16 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S017) | Integra LifeSciences Corporation | 2010-09-16 |
| ACTIVA RC DEEP BRAIN STIMULATOR (P960009/S095) | Medtronic, Inc. | 2010-09-16 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S010) | Bard Peripheral Vascular | 2010-09-15 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S036) | W. L. Gore & Associates, Inc. | 2010-09-15 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S018) | W. L. Gore & Associates, Inc. | 2010-09-15 |
| CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S007) | Ceramtec GmbH | 2010-09-15 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S055) | W. L. Gore & Associates, Inc. | 2010-09-15 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S019) | W. L. Gore & Associates, Inc. | 2010-09-15 |
| PREVELLE SILK (P030032/S010) | Genzyme Biosurgery | 2010-09-15 |
| SPECTRANTICS SLS II LASER SHEATH (P960042/S020) | Spectranetics (Philips) | 2010-09-15 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S029) | W. L. Gore & Associates, Inc. | 2010-09-15 |
| SYNVISC & SYNVISC-ONE (P940015/S019) | Sanofi Genzyme Corp. | 2010-09-15 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S031) | Vascular Solutions, Inc. | 2010-09-15 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S012) | Bard Peripheral Vascular, Inc. | 2010-09-15 |
| SPECTRANTICS SLS II LASER SHEATH (P960042/S021) | Spectranetics (Philips) | 2010-09-15 |
| VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (P030016/S017) | STAAR Surgical Company | 2010-09-15 |
| CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S006) | Ceramtec GmbH | 2010-09-15 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S038) | Abbott Vascular, Inc. | 2010-09-15 |
| E-LUMINEXX VASCULAR STENT (P080007/S003) | Bard Peripheral Vascular, Inc. | 2010-09-15 |
| OVATIO CRT & SITUS OTW LV (P060027/S027) | MicroPort CRM USA, Inc. | 2010-09-14 |
| CONTAK CD/EASYTRAK CRT-D SYSTEM (P010012/S254) | Boston Scientific Corp | 2010-09-14 |
| VENTAK AV AICD SYSTEM (P960040/S234) | Boston Scientific | 2010-09-14 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S044) | Medtronic, Ireland | 2010-09-14 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S012) | Allergan | 2010-09-14 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S058) | Medtronic, Inc. | 2010-09-14 |
| CONTAK RENEWAL TR CRT-P SYSTEM (P030005/S070) | Guidant Corp. | 2010-09-14 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S001) | Boston Scientific Corp | 2010-09-14 |
| CONFIENT (P960040/S231) | Boston Scientific | 2010-09-14 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S109) | Medtronic, Ireland | 2010-09-14 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S039) | Medtronic, Ireland | 2010-09-14 |
| MENTOR MEMORYGEL SILICONE-FILLED BREAST IMPLANT (P030053/S009) | Mentor Corp. | 2010-09-14 |
| LIVIAN & RENEWAL 3 PULSE GENERATORS (P010012/S251) | Boston Scientific Corp | 2010-09-14 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S013) | Bard Peripheral Vascular, Inc. | 2010-09-14 |
| SEPRAFILM (P950034/S033) | Baxter Healthcare Corporation | 2010-09-14 |
| VIGOR DR/SR PACEMAKER SYSTEM (P940031/S069) | Boston Scientific | 2010-09-14 |
| DELTA PACEMAKER SYSTEM (P840068/S047) | Boston Scientific | 2010-09-14 |
| VENTAK PRX AICD SYSTEM (P910077/S108) | Boston Scientific | 2010-09-14 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S011) | ABBOTT MEDICAL | 2010-09-13 |
| ACCESS THERAPY CONTROLLER & ACCESS THERAPY CONTROLLER (P960009/S094) | Medtronic, Inc. | 2010-09-10 |
| MAXUM SYSTEM (P010023/S005) | Ototronix, LLC | 2010-09-10 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S076) | Advanced Bionics | 2010-09-10 |
| ITREL & SYNERGY EZ PATIENT PROGRAMMER (P840001/S162) | Medtronic Neuromodulation | 2010-09-10 |
| PHILOS DR/SR & PHILOS II DR/SR (P950037/S085) | Biotronik, Inc. | 2010-09-10 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S032) | St Jude Medical | 2010-09-10 |
| RESTORE ULTRA (P840001/S161) | Medtronic Neuromodulation | 2010-09-10 |
| ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S093) | Medtronic, Inc. | 2010-09-10 |
| INTERSTIM PATIENT PROGRAMMER (P970004/S091) | Medtronic Neuromodulation | 2010-09-10 |
| VNS THERAPY SYSTEMS (P970003/S113) | LivaNova USA, Inc. | 2010-09-10 |
| RIATA ST OPTIM AND RIATA STS OPTIM LEADS (P950022/S073) | ABBOTT MEDICAL | 2010-09-09 |
| ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S186) | Medtronic, Inc. | 2010-09-09 |
| PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1 (P980049/S059) | MicroPort CRM USA, Inc. | 2010-09-09 |
| PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1 (P060027/S026) | MicroPort CRM USA, Inc. | 2010-09-09 |
| PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P840060/S035) | Alcon Laboratories | 2010-09-09 |
| DEXCOM SEVEN AND SEVEN PLUS (P050012/S030) | Dexcom, Inc. | 2010-09-09 |
| CURRENT + DEVICES & CURRENT ACCEL DEVICES (P030054/S162) | ABBOTT MEDICAL | 2010-09-09 |
| SCULPTRA AESTHETIC (P030050/S008) | Q-Med AB | 2010-09-09 |
| DEXCON SEVEN AND SEVEN PLUS (P050012/S031) | Dexcom, Inc. | 2010-09-09 |
| ACRYSOF MONFOCAL & ACRYSOF TORIC POSTERIOR CHMABER INTRAOCULAR LENSES & ACRYSERT DELIVERY SYSTEM (P930014/S042) | Alcon Laboratories, Inc. | 2010-09-09 |
| PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES (P880087/S017) | Alcon Laboratories | 2010-09-09 |
| ACRYSOF MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S026) | Alcon Research, Ltd. | 2010-09-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S004) | Roche Molecular Systems, Inc. | 2010-09-09 |
| PARADIGM REAL-TIME PUMP (P980022/S082) | Medtronic Minimed | 2010-09-09 |
| PROMOTE DEVICES & PROMOTE ACCEL DEVICES (P910023/S243) | ABBOTT MEDICAL | 2010-09-09 |
| PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P810032/S058) | Alcon Laboratories | 2010-09-09 |
| MOSAIC BIOPROSTHESIS (P990064/S034) | Medtronic, Inc. | 2010-09-08 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S015) | Bard Peripheral Vascular | 2010-09-08 |
| ESTEEM (P090018/S005) | Envoy Medical Corporation | 2010-09-08 |
| INSYNC III CRT-P (P010015/S099) | Medtronic, Inc. | 2010-09-08 |
| DEMA IPGS/ C & T SERIES IPGS (P990001/S076) | Medtronic, Inc. | 2010-09-08 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S016) | Bard Peripheral Vascular | 2010-09-08 |
| COGNIS (P010012/S250) | Boston Scientific Corp | 2010-09-08 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S028) | W. L. Gore & Associates, Inc. | 2010-09-08 |
| RELIANCE ENDOTAK IMPLANTABLE LEADS (P910073/S086) | Boston Scientific | 2010-09-08 |
| LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S019) | Alcon Laboratories, Inc. | 2010-09-08 |
| PARADYM ICDS AND CRT-D DEVICES (P060027/S028) | MicroPort CRM USA, Inc. | 2010-09-08 |
| APEX PTCA & NC QUANTUM APEX PTCA CATHETERS (P860019/S263) | Scimed Life Systems, Inc. | 2010-09-08 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S010) | Spectranetics Corp. | 2010-09-08 |
| MAVERICK2 MONORAIL PTCA DILATATION CATHETER (P860019/S261) | Scimed Life Systems, Inc. | 2010-09-08 |
| SIGMA/MEDTRONIC 350/ENRHYTHM/AT500 IPGS (P980035/S187) | Medtronic, Inc. | 2010-09-08 |
| TELIGEN (P960040/S230) | Boston Scientific | 2010-09-08 |
| BARD ELUMINEXX VASCULAR STENT (P080007/S004) | Bard Peripheral Vascular, Inc. | 2010-09-08 |