| CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II (P850089/S076) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| CONSULTA & SYNCRA CRT-P (P010015/S118) | Medtronic, Inc. | 2011-05-18 |
| PROVIS OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S034) | Alcon Research, Ltd. | 2011-05-18 |
| CELLUGEL (P990023/S011) | Alcon Laboratories | 2011-05-18 |
| SELECTSECURE 4 FRENCH LEAD (P030036/S029) | Medtronic Cardiac Rhythm Disease Management | 2011-05-18 |
| CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S024) | Alcon Laboratories, Inc. | 2011-05-18 |
| CAPSURE FIX LEAD (P090013/S018) | Medtronic, Inc. | 2011-05-18 |
| ATTAIN ABILITY LV/PLUS LV/STRAIGHT LV LEADS (P080006/S023) | Medtronic, Inc. | 2011-05-18 |
| DISCOVISC, VISCOAT AND DUOVISC (P840064/S046) | Alcon Laboratories | 2011-05-18 |
| CAPSURE FIX NOVUS/VITATRON (P930039/S051) | Medtronic, Inc. | 2011-05-18 |
| REVO MRI (P090013/S016) | Medtronic, Inc. | 2011-05-18 |
| CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTEND WEAR (P010019/S022) | Alcon Laboratories, Inc. | 2011-05-18 |
| ADVISA DR (P980035/S217) | Medtronic, Inc. | 2011-05-18 |
| VENTAK PRX AICD SYSTEM (P910077/S111) | Boston Scientific | 2011-05-17 |
| SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN (P990004/S019) | Ferrosan Meidcal Devices A/S | 2011-05-17 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S013) | Medtronic Vascular, Inc. | 2011-05-17 |
| CONTAK CD/EASYTRACK CRT-D SYSTEM (P010012/S265) | Boston Scientific Corp | 2011-05-17 |
| ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV (P100017) | Abbott Molecular, Inc. | 2011-05-17 |
| VIGOR DR/SR PACEMAKER SYSTEM (P940031/S070) | Boston Scientific | 2011-05-17 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S006) | Medtronic Vascular | 2011-05-17 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S004) | Medtronic Vascular | 2011-05-17 |
| TORAY INOUE BALLOON CATHETER (P910054/S005) | Toray Industries (America), Inc. | 2011-05-17 |
| VENTAK AV ACID SYSTEM (P960040/S242) | Boston Scientific | 2011-05-17 |
| CONTAK RENEWAL TR CRT-P SYSTEM (P030005/S073) | Guidant Corp. | 2011-05-17 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S038) | Cook, Inc. | 2011-05-17 |
| DELTA PACEMAKER SYSTEM (P840068/S048) | Boston Scientific | 2011-05-17 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S002) | Medtronic Vascular | 2011-05-17 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S008) | Medtronic Vascular | 2011-05-17 |
| TRIFECTA VALVE (P100029/S001) | ABBOTT MEDICAL | 2011-05-16 |
| FRESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S032) | Abbott Laboratories | 2011-05-16 |
| ADVISA DR (P980035/S216) | Medtronic, Inc. | 2011-05-13 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S107) | Medtronic, Inc. | 2011-05-13 |
| MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER (P890003/S211) | Medtronic, Inc. | 2011-05-13 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S200) | Medtronic, Inc. | 2011-05-13 |
| PROTECTA DR/VR/XT DR/VR (P980016/S293) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| CONSULTA/SYNCRA CRT-P (P010015/S116) | Medtronic, Inc. | 2011-05-13 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S228) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (P780007/S045) | CooperVision, Inc. | 2011-05-13 |
| ARCHITECT CORE (P080023/S007) | Abbott Laboratories | 2011-05-13 |
| DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S104) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| MEDTRONIC CARELINK PROGRAMMER (P850051/S074) | Medtronic, Inc. | 2011-05-13 |
| ARCHITECT CORE-M (P060035/S007) | Abbott Laboratories | 2011-05-13 |
| PROTECTA/PROTECTA XT CRT-D (P010031/S247) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| SUBCUTANEOUS LEAD SYSTEM, TRANSVENE SVC LEAD (P920015/S056) | Medtronic, Inc. | 2011-05-13 |
| VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S273) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| ABBOTT AXSYM AUSAB (P060003/S009) | Abbott Laboratories, Inc. | 2011-05-13 |
| ARCHITECT ANTI-HCV (P050042/S011) | Abbott Laboratories, Inc. | 2011-05-13 |
| TRANSVENE CS/SVC LEAD (P980050/S043) | Medtronic, Inc. | 2011-05-13 |
| PROTECTA DR/VR/XT DR/VR (P980016/S294) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| CONSULTA & SYNCRA CRT-P (P010015/S117) | Medtronic, Inc. | 2011-05-13 |
| LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S012) | Medtronic, Inc. | 2011-05-13 |
| PROLIEVE THERMODILITATION SYSTEM (P030006/S024) | Medifocus, Inc. | 2011-05-13 |
| PROTECTA & PROTECTA XT CRT-DS (P010031/S248) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR (P900061/S098) | Medtronic Cardiac Rhythm Disease Management | 2011-05-13 |
| ARCHITECT AUSAB (P050051/S011) | Abbott Laboratories, Inc. | 2011-05-13 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT (P860003/S059) | Therakos Development Limited | 2011-05-13 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S013) | Abbott Laboratories | 2011-05-13 |
| TRANSVENE CS/SVC LEAD (P980050/S057) | Medtronic, Inc. | 2011-05-13 |
| DEMA IPG/C & T SERIES IPGS (P990001/S082) | Medtronic, Inc. | 2011-05-13 |
| KAPPA 400 DR/SR IPGS (P970012/S081) | Medtronic, Inc. | 2011-05-13 |
| ZETA RX/ULTRA RX/OTW (P970020/S063) | Abbott Vascular, Inc. | 2011-05-12 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S065) | Medtronic, Inc. | 2011-05-12 |
| ANTI-HBC (P010051/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| TRANSVENE SVC LEAD MODEL 6937/SUBCUTANEOUS LEAD MODEL 6996SQ & VARIOUS ACCESSORIES (P920015/S075) | Medtronic, Inc. | 2011-05-12 |
| ABBOTT AXSYM AFP (P820060/S029) | Abbott Laboratories | 2011-05-12 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S068) | Abbott Vascular, Inc. | 2011-05-12 |
| ANCHORING SLEEVE KIT (P030036/S028) | Medtronic Cardiac Rhythm Disease Management | 2011-05-12 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0 (P050018/S014) | Spectranetics Corp. | 2011-05-12 |
| CAPSURE EPI UNIPOLAR/BIPOLAR LEAD (P950024/S030) | Medtronic, Inc. | 2011-05-12 |
| TRANSVENE CS/SVC LEAD (P980050/S060) | Medtronic, Inc. | 2011-05-12 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S069) | Abbott Vascular, Inc. | 2011-05-12 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S055) | Medtronic, Ireland | 2011-05-12 |
| ANTI-HBS (P010052/S008) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| HBSAG (P010050/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| ANTI-HBC IGM (P010053/S007) | Siemens Healthcare Diagnostics Products, Ltd. | 2011-05-12 |
| VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 OTW (P020047/S034) | Abbott Vascular | 2011-05-12 |
| TRANSVENE EPICARDIAL LEAD (P900061/S101) | Medtronic Cardiac Rhythm Disease Management | 2011-05-12 |
| PASSIVE PLUS/ISOFLEX S/P/OPTIM (P960030/S028) | ABBOTT MEDICAL | 2011-05-11 |
| ST JUDE MEDICAL ICDS & CRT-DS (P030054/S187) | ABBOTT MEDICAL | 2011-05-11 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S014) | Allergan | 2011-05-11 |
| FRONTIER/FRONTIER II/ANTHEM/AESCULA (P030035/S064) | ABBOTT MEDICAL | 2011-05-11 |
| QUICKSITE/QUICKFLEX/EPIC HF/+HF/II HF/II +HF/ATLAS HF/ATLAS + HF/ATLAS II HF/ATLAS II + HF/PROMOTE/PROMOTE + (P030054/S142) | ABBOTT MEDICAL | 2011-05-11 |
| ADDVENT/AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGONPHOENIX (P880086/S183) | ABBOTT MEDICAL | 2011-05-11 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S026) | Ortho-Clinical Diagnostics, Inc. | 2011-05-11 |
| LOTRAFILCON A & LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S023) | Alcon Laboratories, Inc. | 2011-05-11 |
| ARCHITECT FREE PSA (P980007/S019) | Abbott Laboratories | 2011-05-11 |
| CADENCE/CADET/CONTOUR/II/MD/ATLAS II/MD/+/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/EPIC II/+/CONVERT (P910023/S227) | ABBOTT MEDICAL | 2011-05-11 |
| ST JUDE MEDICAL ICDS & CRT-DS (P910023/S262) | ABBOTT MEDICAL | 2011-05-11 |
| RIATA/RIATA ST/RIATA ST OPTIM/DURATA (P950022/S067) | ABBOTT MEDICAL | 2011-05-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS (P090028) | Ortho-Clinical Diagnostics, Inc. | 2011-05-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S015) | Ortho-Clinical Diagnostics | 2011-05-11 |
| CRT LEADS (MODELS 1156T, 1158Y AND 1258T). (P030054/S182) | ABBOTT MEDICAL | 2011-05-11 |
| TENDRIL/TENDRIL ST & STS/OPTISENSE (P960013/S055) | ABBOTT MEDICAL | 2011-05-11 |
| ARCHITECT TOTAL PSA (P910007/S028) | Abbott Laboratories | 2011-05-11 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S035) | Hologic, Inc. | 2011-05-10 |
| FAMILY OF PACEMAKERS (P030035/S079) | ABBOTT MEDICAL | 2011-05-10 |
| ADIANA PERMANMENT CONTRACEPTION SYSTEM (P070022/S018) | Hologic, Inc. | 2011-05-10 |
| FAMILY OF CRT-DS (P030054/S183) | ABBOTT MEDICAL | 2011-05-10 |
| FAMILY OF CRT-PS (P880086/S199) | ABBOTT MEDICAL | 2011-05-10 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S032) | Baxter Healthcare Corp | 2011-05-10 |