| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S070) | Abbott Vascular, Inc. | 2012-09-07 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S030) | W. L. Gore & Associates, Inc. | 2012-09-07 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S001) | Abbott Vascular-Cardiac Therapies | 2012-09-07 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S022) | Irvine Biomedical, Inc. | 2012-09-07 |
| ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P030008/S008) | Alcon Laboratories, Inc. | 2012-09-07 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S030) | Abbott Vascular | 2012-09-07 |
| EXABLATE SYSTEM (P040003/S012) | Insightec, Ltd. | 2012-09-07 |
| THERAPY COOL PATH DUO ABLATION CATHETER (P110016/S004) | ABBOTT MEDICAL | 2012-09-07 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S099) | Abbott Vascular, Inc. | 2012-09-07 |
| FLEXTOME CUTTING BALLOON (P950020/S053) | Boston Scientific Corp | 2012-09-07 |
| ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P020050/S008) | Alcon Laboratories, Inc. | 2012-09-07 |
| ACCENT FAMILY OF DEVICES (P880086/S221) | ABBOTT MEDICAL | 2012-09-06 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S022) | Smith & Nephew, Inc. | 2012-09-06 |
| WALLSTENT TRANSJUGULAR PORTOSYSTEMICSHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S034) | Boston Scientific Corp | 2012-09-06 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P100023/S052) | Boston Scientific Corp | 2012-09-06 |
| VERIFLEX CORONARY STENT SYSTEM (MONORAIL) (P040016/S095) | Boston Scientific Scimed, Inc. | 2012-09-06 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S005) | DePuy Orthopaedics, Inc. | 2012-09-06 |
| WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S029) | Boston Scientific Scimed, Inc. | 2012-09-06 |
| ANTHEM FAMILY OF DEVICES (P030035/S099) | ABBOTT MEDICAL | 2012-09-06 |
| VNS THERAPY SYSTEM (P970003/S151) | LivaNova USA, Inc. | 2012-09-06 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S010) | Boston Scientific Corp | 2012-09-06 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S007) | DePuy Orthopaedics, Inc. | 2012-09-06 |
| SJM ELLIPSE AND FORTIFY ASSURA ICDS (P910023/S298) | ABBOTT MEDICAL | 2012-09-06 |
| FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S052) | Boston Scientific Corp | 2012-09-06 |
| TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S008) | Nexus CMF, LLC | 2012-09-06 |
| SJM QUADRA ASSURA AND UNIFY ASSURA CRTDS (P030054/S227) | ABBOTT MEDICAL | 2012-09-06 |
| INJEX MODEL 97791 BUMPY & MODEL 97792 BI-WING ANCHOR KITS (P840001/S199) | Medtronic Neuromodulation | 2012-09-06 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P060008/S094) | Boston Scientific Corp | 2012-09-06 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P110010/S027) | Boston Scientific Corp | 2012-09-06 |
| TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM (P000023/S008) | Nexus CMF, LLC | 2012-09-06 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S023) | Boston Scientific Corporation | 2012-09-06 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S024) | DePuy Orthopaedics, Inc. | 2012-09-06 |
| EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM (P090003/S015) | Boston Scientific Corporation | 2012-09-06 |
| T-SPOT .TB TEST (P070006/S008) | Oxford Immunotec, Ltd. | 2012-09-05 |
| SPECTRANENETICS LASER SHEATHS SLS (P960042/S041) | Spectranetics (Philips) | 2012-09-05 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S021) | Neomend, Inc. | 2012-09-05 |
| CONCERTO II, CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S330) | Medtronic Cardiac Rhythm Disease Management | 2012-09-05 |
| CONSULTA CRT-P, C4TR01 AND SYNCRA CRT-P, C2TR01 (P010015/S173) | Medtronic, Inc. | 2012-09-05 |
| REVO MRI IPG, RVDR01 (P090013/S070) | Medtronic, Inc. | 2012-09-05 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S061) | Spectranetics Corp. | 2012-09-05 |
| DERMAGRAFT (P000036/S011) | Shire Regenerative Medicine | 2012-09-05 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG (P980035/S286) | Medtronic, Inc. | 2012-09-05 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (P970054/S009) | Diasorin | 2012-09-05 |
| BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S010) | Diasorin | 2012-09-05 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S095) | Cochlear Americas | 2012-09-05 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S001) | Roche Molecular Systems, Inc. | 2012-09-05 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S172) | Medtronic, Inc. | 2012-09-05 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S377) | Medtronic Cardiac Rhythm Disease Management | 2012-09-05 |
| BREATH TEK UBTFOR H. PYLORI KIT (P100025/S001) | Meridian Bioscience, Inc. | 2012-09-05 |
| ACTICON NEOSPHINCTER (P010020/S024) | Boston Scientific Corp | 2012-09-04 |
| PROTECTA CRT-D, D334TRG, D334TRM, PROTECTA XT CRT-D, D314TRG, D314TRM (P010031/S327) | Medtronic Cardiac Rhythm Disease Management | 2012-09-04 |
| PROTECTA ICD AND PROTECTA XT ICD (P980016/S374) | Medtronic Cardiac Rhythm Disease Management | 2012-09-04 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S003) | Roche Molecular Systems, Inc. | 2012-09-04 |
| ENVISTA INTRAOCULAR LENS (IOL) (P910056/S011) | Bausch & Lomb, Inc. | 2012-09-04 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S032) | Boston Scientific Corp | 2012-08-31 |
| MAXIMO II ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD (P980016/S375) | Medtronic Cardiac Rhythm Disease Management | 2012-08-31 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S094) | Boston Scientific Scimed, Inc. | 2012-08-31 |
| ADATO SIL-O1 5000 SILICONE OIL (P910071/S014) | Bausch & Lomb | 2012-08-31 |
| EXPRESS CORONARY STENT SYSTEMS (P020009/S090) | Boston Scientific Scimed, Inc. | 2012-08-31 |
| CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD AND MAXIMO II CRT-D (P010031/S328) | Medtronic Cardiac Rhythm Disease Management | 2012-08-31 |
| EN VISTA PIECE HYDROPHOBIC ACRYLIC LENS, MODEL MX60 (P910056/S012) | Bausch & Lomb, Inc. | 2012-08-31 |
| ENDEAOVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S071) | Medtronic, Inc. | 2012-08-31 |
| PENTA LEAD SERIES (P010032/S062) | ABBOTT MEDICAL | 2012-08-31 |
| BD FOCALPOINT SLIDE PROFILER (P950009/S016) | Bd Diagnostics | 2012-08-30 |
| CURRENT, FORTIFY, ELLIPSE ASSURA FAMILY OF ICD DEVICES (P910023/S300) | ABBOTT MEDICAL | 2012-08-30 |
| ATTAIN STARFIX LEAD, 4195 (P060039/S035) | Medtronic, Inc. | 2012-08-30 |
| ARCHITECT AUSAB (P050051/S015) | Abbott Laboratories, Inc. | 2012-08-30 |
| CAPSUREFIX MRI LEAD 6086MRI, REVO MRI IPG, RVDR01 (P090013/S069) | Medtronic, Inc. | 2012-08-30 |
| ATTAIN ABILITY LEADS 4196, 4296 AND 4396 (P080006/S042) | Medtronic, Inc. | 2012-08-30 |
| ARCHITECT ANTI-HCV (P050042/S018) | Abbott Laboratories, Inc. | 2012-08-30 |
| CAPSURE EPICARDIAL PACING LEAD, 4665, 4968 (P950024/S042) | Medtronic, Inc. | 2012-08-30 |
| CAPSURE LEADS, VITATRON CRYSTALINE LEADS, VITATRON EXCELLENCE PS+ LEADS (P830061/S077) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| VITATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG (P990001/S108) | Medtronic, Inc. | 2012-08-30 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO L (P920015/S094) | Medtronic, Inc. | 2012-08-30 |
| CAPSURE LEADS 5038, 5038L, 5038S,IMW14Q,IMW15Q, IMW16Q, IMW17Q, IMW18Q, PRODIGY IPG, 8158 (P890003/S255) | Medtronic, Inc. | 2012-08-30 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD SYNCRA CRT-P (P010015/S171) | Medtronic, Inc. | 2012-08-30 |
| CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEADS, CAPSURE Z NOVUS LEAD, CAPSURE Z NOVUS LEADS, IMPULSE II LEADS (P850089/S089) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S019) | Abbott Laboratories | 2012-08-30 |
| END CAP 6701,EPICARDIAL PATCH LEAD 6721L, 6721M, 6721S,SIZING SLEEVE 6920,UPSIZING SLEEVE 6925 (P900061/S115) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, ENRHYTHM IPG, RELIA IPG, SIGMA DR IPG, SIGMA S I (P980035/S285) | Medtronic, Inc. | 2012-08-30 |
| ARCHITECT CORE (P080023/S015) | Abbott Laboratories | 2012-08-30 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S046) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II ICD, MAXIMO VR ICD, PROTECTA ICD, (P980016/S373) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| EPIC, ATLAS, PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S228) | ABBOTT MEDICAL | 2012-08-30 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO II CRT-D, PROTECT (P010031/S326) | Medtronic Cardiac Rhythm Disease Management | 2012-08-30 |
| ARCHITECT CORE-M (P060035/S014) | Abbott Laboratories | 2012-08-30 |
| RESTYLANE L INJECTABLE GEL (P040024/S056) | Q-Med AB | 2012-08-30 |
| TRANSVENE LEAD, 6937 A (P980050/S075) | Medtronic, Inc. | 2012-08-30 |
| ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY (P110029/S003) | Abbott Laboratories | 2012-08-30 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD, VITATRON CRYSTA (P930039/S071) | Medtronic, Inc. | 2012-08-30 |
| ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES (P040021/S022) | ABBOTT MEDICAL | 2012-08-30 |
| INVIVE CRT-P AND ZOOMVIEW PROGRAMMER (P030005/S086) | Guidant Corp. | 2012-08-29 |
| ARCHITECT FREE PSA (P980007/S026) | Abbott Laboratories | 2012-08-29 |
| ARCHITECT TOTAL PSA (P910007/S035) | Abbott Laboratories | 2012-08-29 |
| RELIATY / MODEL 3145 PACING SYSTEM (P950037/S109) | Biotronik, Inc. | 2012-08-28 |
| CONSULTA CRT-P AND SYNCRA CRT-P (P010015/S170) | Medtronic, Inc. | 2012-08-27 |
| ADVISA DR IPG, A4DR01 (P980035/S284) | Medtronic, Inc. | 2012-08-27 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S098) | Abbott Vascular, Inc. | 2012-08-27 |
| MAXIMO II ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S372) | Medtronic Cardiac Rhythm Disease Management | 2012-08-27 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S325) | Medtronic Cardiac Rhythm Disease Management | 2012-08-27 |