| IMPLANTABLE PULSE GENERATORS (P010032/S049) | ABBOTT MEDICAL | 2012-04-25 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S207) | Medtronic Neuromodulation | 2012-04-25 |
| REVO MRI (P090013/S061) | Medtronic, Inc. | 2012-04-25 |
| ENRHYTHM IPG (P090013/S060) | Medtronic, Inc. | 2012-04-25 |
| REVO MRI IPG (P980035/S267) | Medtronic, Inc. | 2012-04-25 |
| LEGEND PLUS (P930022/S014) | Medtronic, Inc. | 2012-04-25 |
| VITATRON IPGS (P990001/S104) | Medtronic, Inc. | 2012-04-25 |
| INTERSTIM II NEUROSTIMULATOR (P970004/S132) | Medtronic Neuromodulation | 2012-04-25 |
| CONSULTA, INSYNC, INSYNC III, SYNCRA (P010015/S160) | Medtronic, Inc. | 2012-04-25 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA (P980035/S268) | Medtronic, Inc. | 2012-04-25 |
| KAPPA 400 (P970012/S091) | Medtronic, Inc. | 2012-04-25 |
| ACRYSOF #81 MODIFIED LENS CASES (P930014/S060) | Alcon Laboratories, Inc. | 2012-04-25 |
| GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST (P980016/S347) | Medtronic Cardiac Rhythm Disease Management | 2012-04-25 |
| PASYS, PASUS ST, SPECTRAX, SYMBIOS AND SYMBIOS FAMILIES (P820003/S116) | Medtronic Cardiac Rhythm Disease Management | 2012-04-25 |
| ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S139) | Medtronic, Inc. | 2012-04-25 |
| INTERSTIM II NEUROSTIMULATOR (P080025/S029) | Medtronic Neuromodulation | 2012-04-25 |
| GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD (P900061/S114) | Medtronic Cardiac Rhythm Disease Management | 2012-04-25 |
| DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES (P980050/S073) | Medtronic, Inc. | 2012-04-25 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090008/S006) | Roche Diagnostics Corp. | 2012-04-25 |
| ACTIVITRAX, LEGEND, LEGEND II, MINIX, PEMIER, PREVAIL, VITATRON (P850051/S079) | Medtronic, Inc. | 2012-04-25 |
| GUARDIAN REAL-TIME SYSTEM (P980022/S105) | Medtronic Minimed | 2012-04-25 |
| SOLESTA (P100014/S005) | Palette Life Sciences | 2012-04-24 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S013) | Boston Scientific Corp | 2012-04-24 |
| INTERTACH (P860007/S024) | Boston Scientific | 2012-04-23 |
| AMO CLARIFLEX INTRAOCULAR LENSES (IOL) ( MODELS CLRFLX/CLRFLXB/CLRFLXC) & TECNIS CL 3-PIECE INTRAOCULAR LENS (IOL) (P880081/S037) | Johnson & Johnson Surgical Vision, Inc. | 2012-04-23 |
| VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P890061/S020) | Boston Scientific | 2012-04-23 |
| SELUTE LEAD SYSTEM FAMILY (P950001/S023) | Boston Scientific | 2012-04-23 |
| GENESYS HTA SYSTEM (P000040/S021) | Axora Medical, Inc. | 2012-04-23 |
| CONTAK RENEWAL TR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM FAMILY (P030005/S082) | Guidant Corp. | 2012-04-23 |
| AMO REZOOM INTRAOCULAR LENS (IOL) MODEL NXG1 (P960028/S035) | Johnson & Johnson Surgical Vision, Inc. | 2012-04-23 |
| ENDURANT STENT GRAFT SYSTEMS (P100021/S014) | Medtronic Vascular | 2012-04-23 |
| ACUITY STEERABLE LEAD SYSTEM FAMILY (P050046/S014) | Guidant Corp. | 2012-04-23 |
| CYBERLITH (P800019/S013) | Boston Scientific | 2012-04-23 |
| AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (IOL) (MODELS AR40E/AR40E/AR40M/AR40MN) & TECNIS 1 PIECE INTRAOCULAR LENS (P980040/S037) | Johnson & Johnson Surgical Vision, Inc. | 2012-04-23 |
| VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P830060/S070) | Boston Scientific | 2012-04-23 |
| VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES (P940031/S072) | Boston Scientific | 2012-04-23 |
| CAPSUREFIX MRI SURESCAN 5086MRI (P090013/S059) | Medtronic, Inc. | 2012-04-23 |
| INCEPTA, ENERGEN AND PUNTUA IDCS (P960040/S256) | Boston Scientific | 2012-04-23 |
| DELTA/VISTA FAMILIES (P840068/S050) | Boston Scientific | 2012-04-23 |
| MAXIMO II, MAXIMO II ICD, PROTECTA, PROTECTA ICD, PROTECTA XT, PROTECTA XT ICD, SECURA, SECURA ICD,VIRTUOSO II DR/VR ICD (P980016/S346) | Medtronic Cardiac Rhythm Disease Management | 2012-04-23 |
| THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S051) | Boston Scientific | 2012-04-23 |
| AMO TECNIS ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003 (P990080/S036) | Johnson & Johnson Surgical Vision, Inc. | 2012-04-23 |
| RESTYLANE INJECTABLE GEL (P040024/S055) | Q-Med AB | 2012-04-23 |
| RELAY (P910020/S027) | Boston Scientific | 2012-04-23 |
| CONSULTA II CRT-D, CONSULTA, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA, PROTECTA XT (P010031/S298) | Medtronic Cardiac Rhythm Disease Management | 2012-04-23 |
| ENDOTAK LEAD SYSTEM FAMILY (P910073/S101) | Boston Scientific | 2012-04-23 |
| CYBERTACH PULSE GENERATOR SYSTEM (P820022/S005) | Boston Scientific | 2012-04-23 |
| ELECSYS ANTI-HBS (ANTI-HBS) TEST SYSTEM (P010054/S017) | Roche Diagnostics Corp. | 2012-04-23 |
| INCEPTA, ENERGEN AND PUNTUA CRT-DS (P010012/S286) | Boston Scientific Corp | 2012-04-23 |
| VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERSTER DEFIBRILLATOR (AICD) FAMILIES (P910077/S120) | Boston Scientific | 2012-04-23 |
| VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P930035/S021) | Boston Scientific | 2012-04-23 |
| COSMOS (P830026/S080) | Boston Scientific | 2012-04-23 |
| SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEM FAMILIES (P960006/S033) | Boston Scientific | 2012-04-23 |
| RES-Q / RES-Q MICRON PULSE GENERATOR SYSTEM FAMILIES (P940008/S029) | Boston Scientific | 2012-04-23 |
| ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATOR (P960009/S138) | Medtronic, Inc. | 2012-04-20 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S054) | Med-El Corp. | 2012-04-20 |
| INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P080025/S028) | Medtronic Neuromodulation | 2012-04-20 |
| 37751 RECHARGE CHARGING SYSTEM (P960009/S142) | Medtronic, Inc. | 2012-04-20 |
| SPECTRANETICS LASER SHEATH DEVICE (P960042/S031) | Spectranetics (Philips) | 2012-04-20 |
| 37751 RECHARGE CHARGING SYSTEM (P840001/S210) | Medtronic Neuromodulation | 2012-04-20 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S018) | Neomend, Inc. | 2012-04-20 |
| INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P970004/S131) | Medtronic Neuromodulation | 2012-04-20 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S206) | Medtronic Neuromodulation | 2012-04-20 |
| ION PACLITAXEL-ELUTING STENT SYSTEM (P100023/S039) | Boston Scientific Corp | 2012-04-19 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH WIRECLIP TORQUER (P900056/S113) | Boston Scientific Corp | 2012-04-19 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S051) | Boston Scientific Corp | 2012-04-19 |
| PARADYM CRT (P060027/S039) | MicroPort CRM USA, Inc. | 2012-04-19 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S011) | Boston Scientific Corp | 2012-04-19 |
| TAXUS LIBERTE PACLITAXEL-ELYTING CORONARY STENT SYSTEM (P060008/S086) | Boston Scientific Corp | 2012-04-19 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S036) | Bayer Pharma AG | 2012-04-19 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S095) | Boston Scientific Corp | 2012-04-19 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S033) | Boston Scientific | 2012-04-19 |
| DEFLUX (P000029/S071) | Palette Life Sciences | 2012-04-19 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S035) | Boston Scientific Corp | 2012-04-19 |
| CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S009) | Ceramtec GmbH | 2012-04-19 |
| REPLY SR/DR, ESPRIT SR/DR (P950029/S067) | MicroPort CRM USA, Inc. | 2012-04-19 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S025) | Boston Scientific Corp | 2012-04-19 |
| PARADYM VR/DR (P980049/S072) | MicroPort CRM USA, Inc. | 2012-04-19 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S082) | Boston Scientific Scimed, Inc. | 2012-04-19 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S028) | Coloplast Corp. | 2012-04-19 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S085) | Boston Scientific Scimed, Inc. | 2012-04-19 |
| BOND ORACLE HER2 IHC SYSTEM (P090015) | Leica Biosystems | 2012-04-18 |
| DERMAGRAFT (P000036/S008) | Shire Regenerative Medicine | 2012-04-18 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS (P810031/S044) | Johnson & Johnson Surgical Vision, Inc. | 2012-04-18 |
| PARADIGM REAL-TIME INSULIN PUMP AND PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S113) | Medtronic Minimed | 2012-04-18 |
| DEXCOM SEVEN & SEVEN PLUS SYSTEM (P050012/S042) | Dexcom, Inc. | 2012-04-18 |
| DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S002) | DePuy Orthopaedics, Inc. | 2012-04-17 |
| GEM III AT (P980050/S070) | Medtronic, Inc. | 2012-04-16 |
| SECURA/MAXIMO II/PROTECTA /PROTECTA XT/ENTRUST/ENTRUST DR (P980016/S339) | Medtronic Cardiac Rhythm Disease Management | 2012-04-16 |
| CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S292) | Medtronic Cardiac Rhythm Disease Management | 2012-04-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S001) | Ortho-Clinical Diagnostics | 2012-04-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S002) | Ortho-Clinical Diagnostics, Inc. | 2012-04-16 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S024) | Allergan | 2012-04-16 |
| ARCHTECT ANTI-HCV (P050042/S016) | Abbott Laboratories, Inc. | 2012-04-13 |
| IMPLANTABLE CARDIAC PACEMAKER PULSE GENERATOR (P880006/S076) | St. Jude Medical, Inc. | 2012-04-13 |
| FRONTIER (P030035/S090) | ABBOTT MEDICAL | 2012-04-13 |
| ARCHITECT CORE (P080023/S013) | Abbott Laboratories | 2012-04-13 |
| TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P880086/S212) | ABBOTT MEDICAL | 2012-04-13 |
| CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (P960013/S069) | ABBOTT MEDICAL | 2012-04-13 |
| PASSIVE PLUS AND IOSFLEX LEAD FAMILIES (P960030/S035) | ABBOTT MEDICAL | 2012-04-13 |