| AKREOS ADAPT AO HOLDER FOLDER/M160 HOLDER/PARKER GASKET (P060022/S009) | Bausch & Lomb, Inc. | 2011-10-07 |
| NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/EZ STEER THERMOCOOL NAV CATHETERS (P040036/S026) | Biosense Webster, Inc. | 2011-10-07 |
| PREVELLE SILK (P030032/S013) | Genzyme Biosurgery | 2011-10-07 |
| INTERFACE CABLES (P990071/S015) | Biosense Webster, Inc. | 2011-10-07 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S024) | Bard Peripheral Vascular, Inc. | 2011-10-07 |
| ARCHITECT CORE-M (P060035/S010) | Abbott Laboratories | 2011-10-07 |
| PURE-DENT B851 ABSORBABLE DUSTING POWDER (P890070/S005) | Grain Processing Corp. | 2011-10-07 |
| CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES (P950005/S035) | Biosense Webster, Inc. | 2011-10-07 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S201) | ABBOTT MEDICAL | 2011-10-07 |
| CADENCE FAMILY OF ICDS (P910023/S274) | ABBOTT MEDICAL | 2011-10-07 |
| NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR CATHETERS/INTERFACE CABLES (P990025/S029) | Biosense Webster, Inc. | 2011-10-07 |
| SYNVISC AND SYNVISC-ONE (P940015/S022) | Sanofi Genzyme Corp. | 2011-10-07 |
| AXSYM CORE (P060012/S008) | Abbott Laboratories, Inc. | 2011-10-07 |
| CELSIUS & NAVISTAR DS CATHETER/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR DS CATHETER/INTERFACE CABLES (P010068/S025) | Biosense Webster, Inc. | 2011-10-07 |
| FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S040) | Medtronic Cryocath, LP | 2011-10-07 |
| SYNVISC & SYNVISC-ONE (HYLAN G-F 20) (P940015/S023) | Sanofi Genzyme Corp. | 2011-10-07 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S012) | Medtronic Cryocath, LP | 2011-10-07 |
| CELSIUS THERMOCOOL/CELSIUS RMT THERMOCOOL/NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/NAV CATHETERS (P030031/S035) | Biosense Webster, Inc. | 2011-10-07 |
| AXSYM ANTI-HCV (P970027/S015) | Abbott Laboratories | 2011-10-07 |
| ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P040020/S038) | Alcon Research, Ltd. | 2011-10-06 |
| TENDRIL FAMILY OF LEADS (P960013/S067) | ABBOTT MEDICAL | 2011-10-06 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S020) | Boston Scientific Corp | 2011-10-06 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S046) | Medtronic Sofamor Danek USA, Inc. | 2011-10-05 |
| MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY (P040044/S034) | Cordis US Corporation | 2011-10-04 |
| VISION & ML8 CORONARY STENT SYSTEM (P020047/S035) | Abbott Vascular | 2011-10-04 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S085) | Cochlear Americas | 2011-10-04 |
| MULTILINK ZETA CORONARY STENT SYSTEM (P970020/S064) | Abbott Vascular, Inc. | 2011-10-04 |
| PRODISC -L TOTAL DISC REPLACEMENT (P050010/S009) | Centinel Spine, LLC | 2011-10-04 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S072) | Abbott Vascular, Inc. | 2011-10-04 |
| ABBOTT AXSYM AUSAB (P060003/S010) | Abbott Laboratories, Inc. | 2011-10-03 |
| HTA SYSTEM (P000040/S019) | Axora Medical, Inc. | 2011-10-03 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S067) | Medtronic, Inc. | 2011-09-30 |
| LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS (P000009/S046) | Biotronik, Inc. | 2011-09-30 |
| LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S046) | Biotronik, Inc. | 2011-09-30 |
| COROX OTW-L BP LEADS (P070008/S026) | Biotronik, Inc. | 2011-09-30 |
| DEXCOM SEVEN AND SEVEN PLUS SYSTEM (P050012/S041) | Dexcom, Inc. | 2011-09-30 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S021) | Roche Molecular Systems, Inc. | 2011-09-30 |
| EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S098) | Biotronik, Inc. | 2011-09-30 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR & ULTRAFOAM CAST SPONGE/(MCH) ULTRAWRAP/(MCH0 SYRINGEAVITENE (N17600/S025) | Davol Inc., Sub. C. R. Bard, Inc. | 2011-09-29 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S034) | Roche Molecular Systems, Inc. | 2011-09-29 |
| ACRYSOF INTRAOCULAR LENS (IOL) (P930014/S056) | Alcon Laboratories, Inc. | 2011-09-29 |
| PROTECTA/PROTECTA XT (P010031/S273) | Medtronic Cardiac Rhythm Disease Management | 2011-09-29 |
| AFX ACCESSORY STENT GRAFT DELIVERY SYSTEMS (P040002/S033) | Endologix, LLC | 2011-09-29 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE (P800002/S017) | C.R. Bard, Inc. | 2011-09-29 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S004) | Integra LifeSciences Corporation | 2011-09-29 |
| ACRYSOF RESTOR INTRAOCULAR LENS (IOL) (P040020/S037) | Alcon Research, Ltd. | 2011-09-29 |
| PROTECTA/PROTECTA XT (P980016/S319) | Medtronic Cardiac Rhythm Disease Management | 2011-09-29 |
| SOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL (P090022/S008) | Lenstec, Inc. | 2011-09-28 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S043) | ABBOTT MEDICAL | 2011-09-28 |
| CADENCE/CURRENT FAMILY OF ICDS (P910023/S273) | ABBOTT MEDICAL | 2011-09-28 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S074) | St. Jude Medical, Inc. | 2011-09-28 |
| LEGOO (P110003) | Genzyme Corp. | 2011-09-28 |
| FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS (P030035/S088) | ABBOTT MEDICAL | 2011-09-28 |
| EPIC HF/ATLAS+HF/PROMOTE FAMILY OF CRT-DS (P030054/S199) | ABBOTT MEDICAL | 2011-09-28 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S209) | ABBOTT MEDICAL | 2011-09-28 |
| PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY (P020055/S002) | Ventana Medical Systems, Inc. | 2011-09-27 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S073) | Cochlear Americas | 2011-09-27 |
| TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S075) | Boston Scientific Corp | 2011-09-27 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S017) | Boston Scientific Corp | 2011-09-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S016) | Ortho-Clinical Diagnostics | 2011-09-27 |
| ZETA RX CORONARY STENT SYSTEM (P970020/S068) | Abbott Vascular, Inc. | 2011-09-27 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S002) | Cordis US Corporation | 2011-09-27 |
| MULTICETER AUTOMATIC DEFIBRILLATOR IMPLANT ATION YTRIAL WITH CARDIAC RESYNCHRONIZATION THERAPY (P010012/S270) | Boston Scientific Corp | 2011-09-27 |
| XIENCE V RX & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S080) | Abbott Vascular, Inc. | 2011-09-27 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S018) | Boston Scientific Corp | 2011-09-27 |
| VISION RAPID EXCHANGE (RX) & MINI VISION RX MULTI-LINK FAMILY OF CORONARY STENT SYSTEM (CSS) (P020047/S039) | Abbott Vascular | 2011-09-27 |
| EXPRESS2 OTW CORONARY STENT SYSTEM (P020009/S077) | Boston Scientific Scimed, Inc. | 2011-09-27 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S011) | Ventana Medical Systems, Inc. | 2011-09-27 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S022) | Ortho-Clinical Diagnostics, Inc. | 2011-09-27 |
| VERIFLEX (FORMERLY LIBERTE) OTW BARE METAL CORONARY STENT SYSTEM (P040016/S076) | Boston Scientific Scimed, Inc. | 2011-09-27 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S026) | Coloplast Corp. | 2011-09-26 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S035) | Alcon Research, Ltd. | 2011-09-26 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S054) | Alcon Laboratories, Inc. | 2011-09-26 |
| TRIFECTA VALVE (P100029/S002) | ABBOTT MEDICAL | 2011-09-26 |
| ESTEEM (P090018/S010) | Envoy Medical Corporation | 2011-09-23 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S066) | Boston Scientific Corp | 2011-09-23 |
| NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY ABLATION (P030031/S031) | Biosense Webster, Inc. | 2011-09-23 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S013) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER (P090009/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HBS IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBS (P010054/S014) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER (P100031/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 (P090007/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| JUVEDERM HYALURONATE GEL IMPKANTS (P050047/S019) | Allergan | 2011-09-23 |
| PERCLOSE AT AND PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S075) | Abbott Vascular, Inc. | 2011-09-23 |
| FLEXTOME CUTTING BALLOON (P950020/S042) | Boston Scientific Corp | 2011-09-23 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S019) | Boston Scientific Corp | 2011-09-23 |
| ELECSYS FREE PSA IMMUNOASSAY (P000027/S011) | Roche Diagnostics Corp. | 2011-09-23 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S036) | Gynecare, Inc. | 2011-09-23 |
| FC2 FEMALE CONDOM (P080002/S001) | Clear Future, Inc. | 2011-09-23 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S056) | Med-El Corp. | 2011-09-23 |
| ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 (P090008/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG (P990012/S009) | Roche Diagnostics Corp. | 2011-09-23 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S072) | Boston Scientific Scimed, Inc. | 2011-09-23 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S069) | Boston Scientific Scimed, Inc. | 2011-09-23 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032/S003) | Roche Diagnostics Corp. | 2011-09-23 |
| ADAPTA/RELIA/SENSIA/VERSA (P980035/S240) | Medtronic, Inc. | 2011-09-22 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S020) | Bard Peripheral Vascular | 2011-09-22 |
| SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S005) | Lenstec, Inc. | 2011-09-22 |
| APLIGRAF (P950032/S064) | Organogenesis, Inc. | 2011-09-22 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S061) | Therakos Development Limited | 2011-09-22 |