| RESTYLANE INJECTABLE GEL (P040024/S061) | Q-Med AB | 2012-08-10 |
| BELOTERO BALENCE DERMAL FILLER (P090016/S002) | Merz North America, Inc. | 2012-08-10 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM (P970004/S137) | Medtronic Neuromodulation | 2012-08-10 |
| PROPEL SINUS IMPLANT (P100044/S002) | Intersect Ent. | 2012-08-10 |
| UROVYSION BLADDER CANCER KIT ASSAY (P030052/S009) | Abbott Molecular | 2012-08-10 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM (P080025/S034) | Medtronic Neuromodulation | 2012-08-10 |
| OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S026) | Djo, LLC | 2012-08-10 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S015) | Syncardia Systems, LLC | 2012-08-10 |
| ACTIVA RC IMPLANTABLE NEUROSTIMULATOR (P960009/S151) | Medtronic, Inc. | 2012-08-10 |
| MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S367) | Medtronic Cardiac Rhythm Disease Management | 2012-08-10 |
| ITREL 3 AND 4, SYNERGY, SYNERGY VERSITREL SPINAL CORD STIMULATION SYSTEM;RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM (P840001/S220) | Medtronic Neuromodulation | 2012-08-10 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES (P060037/S018) | Zimmer, Inc. | 2012-08-10 |
| PROMOTE AND UNIFY FAMILIES OF CRT-DS AND LEADS (P030054/S217) | ABBOTT MEDICAL | 2012-08-09 |
| ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES (P910023/S295) | ABBOTT MEDICAL | 2012-08-09 |
| UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA (P030054/S223) | ABBOTT MEDICAL | 2012-08-09 |
| EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV) (P100041/S013) | Edwards Lifesciences, LLC | 2012-08-09 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELEASTIC DEVICES (OVD) HEALON, HEALON GV AND HEALON5 (P810031/S045) | Johnson & Johnson Surgical Vision, Inc. | 2012-08-09 |
| LOTRAFILCON SOFT CONTACT LENSES (P010019/S033) | Alcon Laboratories, Inc. | 2012-08-09 |
| ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S063) | Alcon Laboratories, Inc. | 2012-08-09 |
| CURRENT AND FORTIFY FAMILIES OF ICDS (P910023/S290) | ABBOTT MEDICAL | 2012-08-09 |
| PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S013) | Ventana Medical Systems, Inc. | 2012-08-09 |
| VARIOUS FAMILIES OF ACTROS, AXIOS, 8A03, CYLOS, DROMOS, KAIROS, PHILOS, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, & ESTELLA (P950037/S110) | Biotronik, Inc. | 2012-08-08 |
| BELOS AND LEXOS DR/DR-T/VR-T, LUMOS DR/VR-T, XELOS DR-T ICD'S (P000009/S050) | Biotronik, Inc. | 2012-08-08 |
| KRONOS LV-T & VARIOUS FAMILIES OF LUMAX HF CRT-D's; VARIOUS FAMILIES OF LUMAX DR & VR ICD's (P050023/S054) | Biotronik, Inc. | 2012-08-08 |
| STRATOS LV/LV-T CRT-P (P070008/S033) | Biotronik, Inc. | 2012-08-08 |
| MELAFIND (P090012/S001) | Strata Skin Sciences, Inc. | 2012-08-08 |
| TRIFECTA VALVE (P100029/S014) | ABBOTT MEDICAL | 2012-08-08 |
| MERLIN PATIENT CARE SYSTEM ACCESSORIES (P030054/S225) | ABBOTT MEDICAL | 2012-08-08 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S023) | Abbott Vascular | 2012-08-06 |
| SELECTSECURE LEAD (P030036/S045) | Medtronic Cardiac Rhythm Disease Management | 2012-08-06 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEADS (P930039/S069) | Medtronic, Inc. | 2012-08-06 |
| ADAPTA,ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, SIGMA DR IPG, SIGMA S IPG (P980035/S279) | Medtronic, Inc. | 2012-08-06 |
| RESTYLANE L AND PERLANE L INJECTABLE GEL (P040024/S062) | Q-Med AB | 2012-08-06 |
| INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S041) | Medtronic Sofamor Danek USA, Inc. | 2012-08-03 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S013) | Boston Scientific Corporation | 2012-08-03 |
| DEXCOM SEVEN PLUS SYSTEM (P050012/S048) | Dexcom, Inc. | 2012-08-03 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S043) | Medtronic Sofamor Danek USA, Inc. | 2012-08-03 |
| INFUSE BONE GRAFT (P000054/S028) | Medtronic Sofamor Danek USA, Inc. | 2012-08-03 |
| INFUSE BONE GRAFT (P050053/S019) | Medtronic, Inc. | 2012-08-03 |
| INFUSE BONE GRAFT (P050053/S021) | Medtronic, Inc. | 2012-08-03 |
| INFUSE BONE GRAFT (P000054/S030) | Medtronic Sofamor Danek USA, Inc. | 2012-08-03 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S092) | Boston Scientific Corp | 2012-08-02 |
| ACTICON NEOSPHINCTER (P010020/S025) | Boston Scientific Corp | 2012-08-02 |
| FINELINE 11 AND THINLINE II (P960004/S053) | Boston Scientific | 2012-08-02 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S046) | Abbott Vascular | 2012-08-02 |
| AMS UROLUME ENDOPROSTHESIS (P920023/S031) | Boston Scientific Corp | 2012-08-02 |
| OXFORD PATIAL KNEE SYSTEM (P010014/S036) | Biomet Manufacturing Corp | 2012-08-02 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S044) | Boston Scientific Corp | 2012-08-02 |
| MAXIMO II DF-4, MAXIMO II, DF-4, PROTECTA DF-4, PROTECTA ICD, PROTECTA XT DF-4, PROTECTA XT ICD, SECURA DF-4, SECURA IC (P010031/S317) | Medtronic Cardiac Rhythm Disease Management | 2012-08-01 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA DF-DF-4, PROTECTA XT (P980016/S365) | Medtronic Cardiac Rhythm Disease Management | 2012-08-01 |
| ACTIVA RC IMPLANTABLE NEUROSTIMULAOR 37612 (P960009/S150) | Medtronic, Inc. | 2012-08-01 |
| RESTORESENSOR, 37714 (P840001/S222) | Medtronic Neuromodulation | 2012-08-01 |
| RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR 37712, RESTORESENSOR IMPLANTABLE NEUROSTIMULATOR 37714 (P840001/S218) | Medtronic Neuromodulation | 2012-08-01 |
| CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA (P010032/S056) | ABBOTT MEDICAL | 2012-08-01 |
| REPLY/ESPIRIT PACEMAKER (P950029/S070) | MicroPort CRM USA, Inc. | 2012-07-31 |
| RAPID PROGRAMMER (P010032/S053) | ABBOTT MEDICAL | 2012-07-31 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S040) | Spectranetics (Philips) | 2012-07-31 |
| HER2 CISH PHARMDX KIT (P100024/S002) | Dako Denmark A/S | 2012-07-31 |
| PARADYM AND PARADYM RF ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) (P980049/S076) | MicroPort CRM USA, Inc. | 2012-07-31 |
| OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P860047/S026) | Bausch & Lomb, Inc. | 2012-07-31 |
| ARCHITECT ANTI-HCV (P050042/S017) | Abbott Laboratories, Inc. | 2012-07-31 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S060) | Spectranetics Corp. | 2012-07-31 |
| HER2 FISH PHARMDX KIT (P040005/S008) | Agilent Technologies Singapore (International) Pte , Ltd. | 2012-07-31 |
| OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM (P110043) | Abbott Vascular-Cardiac Therapies | 2012-07-31 |
| CRT-D (CARDIACRESYNCHRONIZATION THERAPY DEFIBRILLATOR) (P060027/S044) | MicroPort CRM USA, Inc. | 2012-07-31 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S069) | Medtronic, Inc. | 2012-07-31 |
| PARADYM RF CRT-D (P060027/S043) | MicroPort CRM USA, Inc. | 2012-07-30 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S033) | Vistakon, Division of Johnson & Johnson Vision Car | 2012-07-30 |
| VIFILCON A SOFT CONTACT LENSES (P820021/S034) | Alcon Laboratories, Inc. | 2012-07-30 |
| PACEMAKERS, REPLY SR AND DR, ESPIRIT SR AND DR (P950029/S069) | MicroPort CRM USA, Inc. | 2012-07-30 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S066) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2012-07-30 |
| ICD/CRT PARADYM R AND DR, PARADYM CRT-D, PARADYM RF-VR AND DR (P980049/S075) | MicroPort CRM USA, Inc. | 2012-07-30 |
| AMVISC/AMVISC PLUS OVDS (P810025/S031) | Bausch & Lomb, Inc. | 2012-07-27 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S023) | Boston Scientific Corp | 2012-07-27 |
| AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURGICAL DEVICE (P810025/S032) | Bausch & Lomb, Inc. | 2012-07-27 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S091) | Boston Scientific Corp | 2012-07-26 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S048) | Boston Scientific Corp | 2012-07-26 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S087) | Boston Scientific Scimed, Inc. | 2012-07-26 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S083) | ABBOTT MEDICAL | 2012-07-26 |
| RESTYLANE INJECTABLE GEL (P040024/S060) | Q-Med AB | 2012-07-26 |
| REVO MRI IPG (P090013/S065) | Medtronic, Inc. | 2012-07-26 |
| ADVISA DR IPG, ENRHYTHM IPG (P980035/S276) | Medtronic, Inc. | 2012-07-26 |
| PROMUS ELEMENT PLUS EVEROLIMUS CHROMIUM CORONARY STENT SYSTEM (P110010/S022) | Boston Scientific Corp | 2012-07-26 |
| CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM (P970029/S020) | Cryolife, Inc. | 2012-07-26 |
| ZENITH FENESTRATED AAA ENDOVASULAR GRAFT (P020018/S045) | Cook, Inc. | 2012-07-26 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S165) | Medtronic, Inc. | 2012-07-26 |
| VNS THERAPY SYSTEM (P970003/S150) | LivaNova USA, Inc. | 2012-07-26 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S090) | Boston Scientific Scimed, Inc. | 2012-07-26 |
| MECHANICAL HEART VALVES (P810002/S082) | ABBOTT MEDICAL | 2012-07-25 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S058) | Spectranetics Corp. | 2012-07-25 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S039) | Biosense Webster, Inc. | 2012-07-25 |
| VERIFLEX (LIBERTE) MONORAIL CORONARY STENT SYSTEM (P040016/S092) | Boston Scientific Scimed, Inc. | 2012-07-25 |
| SLS SPECTRECTRANETICS LASER SHEATHS (P960042/S039) | Spectranetics (Philips) | 2012-07-25 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S092) | Boston Scientific Corp | 2012-07-25 |
| ADVISA DR IPG (P980035/S275) | Medtronic, Inc. | 2012-07-25 |
| STOCKERT RADIOFREQUENCY GENERATOR (P990071/S019) | Biosense Webster, Inc. | 2012-07-25 |
| NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S033) | Biosense Webster, Inc. | 2012-07-25 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S034) | Baxter Healthcare Corp | 2012-07-25 |
| NAVISTAR/CELSIUS DS CATHETERS (P010068/S029) | Biosense Webster, Inc. | 2012-07-25 |
| INCEPTA, TELIGEN, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S259) | Boston Scientific | 2012-07-25 |