| FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS (P030035/S091) | ABBOTT MEDICAL | 2011-12-30 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S014) | Anika Therapeutics, Inc. | 2011-12-30 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S005) | Abbott Vascular | 2011-12-30 |
| ST JUDE MEDICAL ICDS/CRT-DS AND LEADS (P030054/S209) | ABBOTT MEDICAL | 2011-12-30 |
| ST JUDE MEDICAL ICDS/CRT-DS AND LEADS (P910023/S282) | ABBOTT MEDICAL | 2011-12-30 |
| AFFINITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S213) | ABBOTT MEDICAL | 2011-12-30 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST (P050028/S019) | Roche Molecular Systems, Inc. | 2011-12-29 |
| COBAS AMPLICOR HCV TEST, V2.0 (P000012/S031) | Roche Molecular Systems, Inc. | 2011-12-29 |
| COBAS HPV TEST (P100020/S001) | Roche Molecular Systems, Inc. | 2011-12-29 |
| AMPLICOR HCV TEST V2.0 (P000010/S022) | Roche Molecular Systems, Inc. | 2011-12-29 |
| BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (P970055/S012) | Diasorin | 2011-12-29 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST (P060030/S020) | Roche Molecular Systems, Inc. | 2011-12-29 |
| INTERSTIM II (P080025/S023) | Medtronic Neuromodulation | 2011-12-28 |
| INTERSTIM II (P970004/S126) | Medtronic Neuromodulation | 2011-12-28 |
| PARADIGM REAL-TIME INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K) (P980022/S106) | Medtronic Minimed | 2011-12-28 |
| ACTIVA PC/SC/RC/DBS NEUROSTIMULATOR EXTERNAL (P960009/S133) | Medtronic, Inc. | 2011-12-28 |
| SYNCROMED II (P860004/S166) | Medtronic, Inc. | 2011-12-28 |
| SCS NEUROSTIMULATOR EXTERNAL/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED/RESTORESENSOR (P840001/S200) | Medtronic Neuromodulation | 2011-12-28 |
| APLIGRAF (P950032/S066) | Organogenesis, Inc. | 2011-12-28 |
| CGMS GOLD MONITOR (MMT-7102W) (P980022/S101) | Medtronic Minimed | 2011-12-28 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S052) | Spectranetics Corp. | 2011-12-27 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S033) | Spectranetics (Philips) | 2011-12-27 |
| CONCERTO/CONCERTO II, CONSULTA, MAXIMO II, PROTECTA/PROTECTA XT (P010031/S285) | Medtronic Cardiac Rhythm Disease Management | 2011-12-23 |
| ENTRUST, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO/VIRTUOSO II (P980016/S332) | Medtronic Cardiac Rhythm Disease Management | 2011-12-23 |
| CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES (P950005/S036) | Biosense Webster, Inc. | 2011-12-23 |
| OVAL PATCH LEAD (P900061/S109) | Medtronic Cardiac Rhythm Disease Management | 2011-12-23 |
| LEAD TERMINAL CAP (P940008/S028) | Boston Scientific | 2011-12-23 |
| ADVISA (P980035/S254) | Medtronic, Inc. | 2011-12-23 |
| SUTURE SLEEVE ACCESSORY (P010012/S273) | Boston Scientific Corp | 2011-12-23 |
| RF CONTRACTR/RF CONDUCTR/RF MARINR/RF MARINR 5FR/RF ENHANCER II FAMILIES OF ABLATION CATHETERS (P930029/S035) | Medtronic, Inc. | 2011-12-23 |
| VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S142) | LivaNova USA, Inc. | 2011-12-23 |
| CONSULTA CRT-P/SYNCRA CRT-P (P010015/S149) | Medtronic, Inc. | 2011-12-23 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S045) | Medtronic Sofamor Danek USA, Inc. | 2011-12-23 |
| CELSIUS RMT THERMOCOOL MAGNETIC CATHETER (P040036/S028) | Biosense Webster, Inc. | 2011-12-23 |
| NEXGEN COMPLETE KNEE SOLUTION (P060037/S015) | Zimmer, Inc. | 2011-12-23 |
| NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS (P030031/S037) | Biosense Webster, Inc. | 2011-12-23 |
| AXSYM AUSAB (LN 3C74) (P060003/S011) | Abbott Laboratories, Inc. | 2011-12-22 |
| AXSYM CORE 2.0 (LN 8B88) (P060012/S009) | Abbott Laboratories, Inc. | 2011-12-22 |
| PRODISC -C TOTAL DISC REPLACEMENT (P070001/S010) | Centinel Spine, LLC | 2011-12-22 |
| AXSYM TOTAL PSA (LN 3C19) (P910007/S032) | Abbott Laboratories | 2011-12-22 |
| AXSYM AFP (LN 7A48) (P820060/S030) | Abbott Laboratories | 2011-12-22 |
| AXSYM FREE PSA (LN 3C20) (P980007/S023) | Abbott Laboratories | 2011-12-22 |
| AXSYM CORE-M 2.0 (LN 3B89) (P060009/S006) | Abbott Laboratories, Inc. | 2011-12-22 |
| AXSYM HBSAG/CONFIRMATORY (LN 9B01) (P050049/S009) | Abbott Laboratories, Inc. | 2011-12-22 |
| TRIFECTA HEART VALVE (P100029/S003) | ABBOTT MEDICAL | 2011-12-22 |
| AXSYM ANTI-HCV (LN 5C36) (P970027/S017) | Abbott Laboratories | 2011-12-22 |
| ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES (P040021/S016) | ABBOTT MEDICAL | 2011-12-22 |
| ARCHITECT CORE (P080023/S012) | Abbott Laboratories | 2011-12-21 |
| ARCHITECT AUSAB (P050051/S014) | Abbott Laboratories, Inc. | 2011-12-21 |
| EPG-SINGLE AND DUAL CHAMBER (P820003/S114) | Medtronic Cardiac Rhythm Disease Management | 2011-12-21 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S015) | Roche Diagnostics Corp. | 2011-12-21 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S016) | Abbott Laboratories | 2011-12-21 |
| THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER (P030031/S025) | Biosense Webster, Inc. | 2011-12-21 |
| CARELINK PROGRAMMER CRM PROGRAMMER (P890003/S242) | Medtronic, Inc. | 2011-12-21 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S014) | Zimmer, Inc. | 2011-12-21 |
| THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER (P990071/S009) | Biosense Webster, Inc. | 2011-12-21 |
| ARCHITECT CORE-M (P060035/S013) | Abbott Laboratories | 2011-12-21 |
| ARCHITECT TOTAL PSA (P910007/S033) | Abbott Laboratories | 2011-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S067) | W. L. Gore & Associates, Inc. | 2011-12-21 |
| SURGICAL ABSORBABLE HEMOSTAT (N12159/S029) | ETHICON, Inc. | 2011-12-21 |
| NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S010) | Neomend, Inc. | 2011-12-21 |
| THE GORE TAG THORACIC ENDOPROSTHESIS (P040043/S041) | W. L. Gore & Associates, Inc. | 2011-12-21 |
| THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER (P990071/S013) | Biosense Webster, Inc. | 2011-12-21 |
| STAARVISC II, OPTIVISC/ANIKAVISC/SODIUM HYALURONATE (P000046/S020) | Anika Therapeutics, Inc. | 2011-12-21 |
| ACHITECT ANTI-HCV (P050042/S015) | Abbott Laboratories, Inc. | 2011-12-21 |
| CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S041) | Corcym S.r.l. | 2011-12-21 |
| HEARTMATE XVE LVAS (P920014/S031) | Thoratec Corp | 2011-12-21 |
| ELECSYS FREE PSA IMMUNOASSAY (P000027/S013) | Roche Diagnostics Corp. | 2011-12-21 |
| ARCHITECT FREE PSA (P980007/S024) | Abbott Laboratories | 2011-12-21 |
| THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER (P030031/S034) | Biosense Webster, Inc. | 2011-12-21 |
| THORATEC VAD SYSTEM (P870072/S046) | Thoratec Laboratories Corp. | 2011-12-21 |
| HEARTMATE II LVAS (P060040/S014) | ABBOTT MEDICAL | 2011-12-21 |
| VNS THERAPY SYSTEM (P970003/S140) | LivaNova USA, Inc. | 2011-12-20 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SOFTWARE SYSTEM (P980022/S099) | Medtronic Minimed | 2011-12-20 |
| BIOFINITY (COMFILCON) SOFT CONTACT LENS (P080011/S005) | CooperVision, Inc. | 2011-12-20 |
| MYSENTRY SYSTEM (P980022/S075) | Medtronic Minimed | 2011-12-20 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S019) | DePuy Orthopaedics, Inc. | 2011-12-20 |
| CLEARSOFT (METHAFILCON A) SOFT COTACT LENS (P850079/S050) | CooperVision, Inc. | 2011-12-20 |
| SOFTEC HD INTRAOCULAR LENS (IOL) (P090022/S007) | Lenstec, Inc. | 2011-12-20 |
| NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S042) | Hologic, Inc. | 2011-12-20 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER WITH LUMEN (P020052/S009) | St Jude Medical | 2011-12-20 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S016) | Spectranetics Corp. | 2011-12-20 |
| LIVEWIRE TC AND SAFIRE ABLATION CATHETERS (P960016/S038) | St Jude Medical | 2011-12-20 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S088) | Cochlear Americas | 2011-12-20 |
| SPRINT QUATTRO/SUBCUTANEOUS LEAD (P920015/S085) | Medtronic, Inc. | 2011-12-19 |
| CAPSUREFIX MRI (P090013/S048) | Medtronic, Inc. | 2011-12-19 |
| EPIC VALVE (P040021/S019) | ABBOTT MEDICAL | 2011-12-19 |
| CAPSURE (P830061/S074) | Medtronic Cardiac Rhythm Disease Management | 2011-12-19 |
| TRANSVENE CS/SVC LEAD (P980050/S069) | Medtronic, Inc. | 2011-12-19 |
| ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM (P110001/S002) | Abbott Vascular | 2011-12-19 |
| CAPSURE (P890003/S241) | Medtronic, Inc. | 2011-12-19 |
| CAPSURE/SUREFIX (P930039/S065) | Medtronic, Inc. | 2011-12-19 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S039) | Medtronic, Inc. | 2011-12-19 |
| ATTAIN (P010015/S150) | Medtronic, Inc. | 2011-12-19 |
| SELECTSECURE (P030036/S038) | Medtronic Cardiac Rhythm Disease Management | 2011-12-19 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S041) | Cordis US Corporation | 2011-12-19 |
| ATTAIN STARFIX (P060039/S032) | Medtronic, Inc. | 2011-12-19 |
| ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT (P080006/S037) | Medtronic, Inc. | 2011-12-19 |
| CAPSURE Z NOVUS (P850089/S086) | Medtronic Cardiac Rhythm Disease Management | 2011-12-19 |
| CARDIOGENESIS TMR SYSTEM (P970029/S018) | Cryolife, Inc. | 2011-12-16 |