| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S069) | Boston Scientific Corp | 2009-02-20 |
| ISPAN PERFLUOROPROPANE C3F8 (P900066/S008) | Airgas Therapeutics, LLC | 2009-02-19 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025/S004) | Medtronic, Inc. | 2009-02-19 |
| MAVERICK OTW/MAVERICK 2 MONORAIL PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S231) | Scimed Life Systems, Inc. | 2009-02-19 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S002) | Bausch & Lomb, Inc. | 2009-02-18 |
| HEALON D SODIUM HYALURONATE SOLUTION (P880031/S016) | Abbott Medical Optics, Inc. | 2009-02-18 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S042) | W. L. Gore & Associates, Inc. | 2009-02-18 |
| REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S008) | Smith & Nephew, Inc. | 2009-02-18 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S095) | Boston Scientific Corp | 2009-02-17 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S014) | Medtronic, Inc. | 2009-02-17 |
| DEXCOM SEVEN SYSTEM (P050012/S016) | Dexcom, Inc. | 2009-02-13 |
| AMS 800 ARTIFICAL URINARY SPHINCTER (P000053/S020) | Boston Scientific Corp | 2009-02-13 |
| ENTRUST DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S173) | Medtronic Cardiac Rhythm Disease Management | 2009-02-13 |
| STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR (P880091/S030) | Staar Surgical Co. | 2009-02-13 |
| ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER (P010020/S012) | Boston Scientific Corp | 2009-02-13 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S010) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S043) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| ZIMMER NEXGEN LPS-FLEX MOBILE & LPS-MOBILE BEARING KNEE SYSTEMS (P060037/S006) | Zimmer, Inc. | 2009-02-13 |
| RENEWAL, RENEWAL RF, RENEWAL ZODIAC, FRONTIER AND LIVIAN (P010012/S200) | Boston Scientific Corp | 2009-02-13 |
| CONFIENT, FRONTIER, AND VITALITY (P960040/S187) | Boston Scientific | 2009-02-13 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S027) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S016) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S013) | W. L. Gore & Associates, Inc. | 2009-02-13 |
| KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM (N980003/S007) | Djo Surgical | 2009-02-13 |
| LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM (P070014) | Bard Peripheral Vascular, Inc. | 2009-02-13 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S010) | Smith & Nephew, Inc. | 2009-02-13 |
| RESTYLANE INJECTABLE GELS (P040024/S033) | Q-Med AB | 2009-02-12 |
| GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S025) | Gynecare, Inc. | 2009-02-11 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S011) | Abbott Vascular, Inc. | 2009-02-11 |
| MODEL 5441 EPG PLASTIC COVER (P820003/S088) | Medtronic Cardiac Rhythm Disease Management | 2009-02-11 |
| ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO/MAXIMO II/SECURA/MARQUIS/INSTRINSIC 35J ICDS (P980016/S174) | Medtronic Cardiac Rhythm Disease Management | 2009-02-10 |
| MAXIMO II CRT-D/CONCERTO ICD/CONSULTA CRT-D/INSYNC III MARQUIS/PROTECT/INSYNC SENTRY ICD/CONCERTO II CRT-D (P010031/S140) | Medtronic Cardiac Rhythm Disease Management | 2009-02-10 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S003) | Abbott Molecular, Inc. | 2009-02-10 |
| IMMULITE & IMMULITE 2000 HBSAG ASSAY (P010050/S007) | Siemens Healthcare Diagnostics Products, Ltd. | 2009-02-09 |
| NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S020) | Hologic, Inc. | 2009-02-06 |
| SYNCHROMED INFUSION SYSTEM (P860004/S102) | Medtronic, Inc. | 2009-02-06 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S006) | Allergan | 2009-02-06 |
| ISOMED INFUSION SYSTEM (P990034/S012) | Medtronic, Inc. | 2009-02-06 |
| NAVISTAR & CELSIUS THERMOCOOL CATHETERS (P030031/S011) | Biosense Webster, Inc. | 2009-02-06 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S007) | Cerenovus, Inc. | 2009-02-06 |
| ACRYSERT DELIVERY SYSTEM (P930014/S024) | Alcon Laboratories, Inc. | 2009-02-05 |
| NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC / ABLATION CATHETERS (P040036/S007) | Biosense Webster, Inc. | 2009-02-05 |
| ACRYSOF IQ TORIC INTRAOCULAR LENS (IOL) (P930014/S029) | Alcon Laboratories, Inc. | 2009-02-05 |
| REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1 (P900022/S012) | MicroPort CRM USA, Inc. | 2009-02-04 |
| SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD (P060027/S008) | MicroPort CRM USA, Inc. | 2009-02-04 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S006) | ABBOTT MEDICAL | 2009-02-04 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S113) | ABBOTT MEDICAL | 2009-02-04 |
| ISOLINE 2CR/2CT DEFIBRILLATION LEADS (P980049/S044) | MicroPort CRM USA, Inc. | 2009-02-04 |
| CADENCE FAMILY OF ICDS (P910023/S199) | ABBOTT MEDICAL | 2009-02-04 |
| SYMPHONY SR/DR & RHAPSODY SR/DR (P950029/S039) | MicroPort CRM USA, Inc. | 2009-02-04 |
| VARIOUS FAMILIES OF PACEMAKERS (P980035/S114) | Medtronic, Inc. | 2009-02-04 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S021) | Hologic, Inc. | 2009-02-04 |
| RADIESSE INJECTABLE IMPLANT (P050052/S018) | Merz North America, Inc. | 2009-02-03 |
| OVATIO CRT 6750 (P060027/S005) | MicroPort CRM USA, Inc. | 2009-02-03 |
| RADIESSE INJECTABLE IMPLANT (P050037/S017) | Merz North America, Inc. | 2009-02-03 |
| ZILVER VASCULAR STENT (P050017/S003) | Cook Ireland, Ltd. | 2009-02-03 |
| ZILVER VASCULAR STENT (P050017/S002) | Cook Ireland, Ltd. | 2009-02-03 |
| OVATIO VR 6250 & DR 6550 (P980049/S041) | MicroPort CRM USA, Inc. | 2009-02-03 |
| MEDTRONIC ATTAIN STARFIX (P060039/S002) | Medtronic, Inc. | 2009-02-02 |
| XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080021) | Bausch & Lomb, Incorporated | 2009-02-02 |
| ACRYSOF INTRAOCULAR LENS (P930014/S030) | Alcon Laboratories, Inc. | 2009-01-30 |
| FEMCARE FILSHIE CLIP (P920046/S006) | Femcare , Ltd. | 2009-01-30 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S062) | Medtronic Neuromodulation | 2009-01-30 |
| CARELINK PROGRAMMER (P890003/S146) | Medtronic, Inc. | 2009-01-30 |
| PARADIGM REAL-TIME INSULIN PUMP (P980022/S041) | Medtronic Minimed | 2009-01-30 |
| GENESIS RC AND EON NEUROSTIMULATION SYSTEMS (P010032/S025) | ABBOTT MEDICAL | 2009-01-29 |
| UROLOGIX TARGIS SYSTEM (P970008/S042) | Urologix, LLC | 2009-01-29 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S008) | Stryker Corp. | 2009-01-28 |
| ABBOTT ARCHITECT ANTI-HCV (P050042/S004) | Abbott Laboratories, Inc. | 2009-01-28 |
| ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S003) | William Cook Europe Aps | 2009-01-27 |
| CARELINK PERSONAL SOFTWARE (P980022/S043) | Medtronic Minimed | 2009-01-27 |
| AMPLATZER DUCT OCCLUDER (P020024/S022) | ABBOTT MEDICAL | 2009-01-27 |
| WRENCH & REPLACEMENT SETSCREW ACCESSORY KIT & ACCESSORY KIT (P890003/S162) | Medtronic, Inc. | 2009-01-27 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S028) | ABBOTT MEDICAL | 2009-01-27 |
| LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT (P900061/S082) | Medtronic Cardiac Rhythm Disease Management | 2009-01-27 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S008) | ABBOTT MEDICAL | 2009-01-27 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S005) | Spectranetics Corp. | 2009-01-27 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX (P860057/S051) | Edwards Lifesciences, LLC | 2009-01-27 |
| RESTYLANE INJECTABLE GEL (P040024/S032) | Q-Med AB | 2009-01-27 |
| ITREL 3/SYNERGY/RESTORE PRIME/PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE NEUROSTIMULATOR (P840001/S127) | Medtronic Neuromodulation | 2009-01-26 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S012) | W. L. Gore & Associates, Inc. | 2009-01-26 |
| INTERSTIM FAMILY OF NEUROSTIMULATORS (P970004/S068) | Medtronic Neuromodulation | 2009-01-26 |
| ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S061) | Medtronic, Inc. | 2009-01-26 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP (P870077/S026) | Edwards Lifesciences, LLC | 2009-01-23 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S007) | Zimmer, Inc. | 2009-01-23 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S023) | Medtronic, Inc. | 2009-01-23 |
| PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S092) | Boston Scientific Corp | 2009-01-23 |
| INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS (P030005/S055) | Guidant Corp. | 2009-01-23 |
| TLC-II PORTABLE VAD DRIVER (P870072/S035) | Thoratec Laboratories Corp. | 2009-01-21 |
| ACCULINK/RX ACCULINK CAROTID STENT SYSTEMS (P040012/S029) | Abbott Vascular | 2009-01-21 |
| ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS (P030035/S051) | ABBOTT MEDICAL | 2009-01-16 |
| MEDTRONIC RESPORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S123) | Medtronic Neuromodulation | 2009-01-16 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S029) | Medtronic, Inc. | 2009-01-16 |
| AIR OPTIX FOR ASTIGMATISM (P010019/S011) | Alcon Laboratories, Inc. | 2009-01-16 |
| ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR PACEMAKERS (P880086/S172) | ABBOTT MEDICAL | 2009-01-16 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S032) | Medtronic, Ireland | 2009-01-16 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S005) | Medtronic Vascular | 2009-01-16 |
| INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM (P970004/S065) | Medtronic Neuromodulation | 2009-01-16 |
| MEDTRONIC ATTAIN STARFIX (P060039/S003) | Medtronic, Inc. | 2009-01-16 |
| ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR PACEMAKERS (P880086/S171) | ABBOTT MEDICAL | 2009-01-16 |