| CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES (P900060/S048) | Corcym S.r.l. | 2012-03-07 |
| VISION RX, VISION OTW MINI VISION RX, MINI VISION OTW (P020047/S043) | Abbott Vascular | 2012-03-07 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S013) | Abbott Vascular | 2012-03-07 |
| INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS (P980016/S335) | Medtronic Cardiac Rhythm Disease Management | 2012-03-07 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023) | Medtronic Vascular, Inc. | 2012-03-07 |
| GELFOAM (N18286/S023) | Pfizer, Inc. | 2012-03-06 |
| ESOPHAGEAL PACING SYSTEM (P860008/S020) | Cardio Command | 2012-03-06 |
| MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM) (P980016/S336) | Medtronic Cardiac Rhythm Disease Management | 2012-03-05 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S060) | Med-El Corp. | 2012-03-05 |
| TALENT CAPTIVIA STENT GRAFT SYSTEM (P070007/S034) | Medtronic Vascular | 2012-03-05 |
| STRATOS LV/LV-T (P070008/S029) | Biotronik, Inc. | 2012-03-05 |
| EASYTRAK 3 IS-1 LEADS (P010012/S274) | Boston Scientific Corp | 2012-03-05 |
| LUMAX ICDS AND CRT-DS (P050023/S051) | Biotronik, Inc. | 2012-03-05 |
| ACUITY STEERABLE IS-1 LEADS (P050046/S012) | Guidant Corp. | 2012-03-05 |
| VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S103) | Biotronik, Inc. | 2012-03-05 |
| MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM) (P010031/S289) | Medtronic Cardiac Rhythm Disease Management | 2012-03-05 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S035) | Boston Scientific Corp | 2012-03-02 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S012) | Abbott Vascular | 2012-03-02 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P010027/S005) | Aaren Scientific | 2012-03-02 |
| XIENCE V EVEROLIMUS CORONARY STENT SYSTEM & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S089) | Abbott Vascular, Inc. | 2012-03-02 |
| THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S065) | Therakos Development Limited | 2012-03-02 |
| ARCHITECT CORE (P080023/S011) | Abbott Laboratories | 2012-03-02 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S024) | Boston Scientific Corp | 2012-03-02 |
| CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA (P010032/S047) | ABBOTT MEDICAL | 2012-03-02 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S084) | Boston Scientific Scimed, Inc. | 2012-03-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY SYSTEM (P060008/S085) | Boston Scientific Corp | 2012-03-02 |
| ANTERIOR CHAMBER INTRAOCULAR LENS (P010027/S004) | Aaren Scientific | 2012-03-02 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S081) | Boston Scientific Scimed, Inc. | 2012-03-02 |
| PROMOTE Q/PROMOTE QUADRA/UNIFY QUADRA/QUARTET CRT-DS (P030054/S214) | ABBOTT MEDICAL | 2012-03-02 |
| LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S029) | Alcon Laboratories, Inc. | 2012-03-02 |
| ARCHITECT CORE-M (P060035/S011) | Abbott Laboratories | 2012-03-02 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S017) | Neomend, Inc. | 2012-03-01 |
| COGNIS, CONTAK RENEWAL 3/3 HE, LIVIAN CRT-DS (P010012/S281) | Boston Scientific Corp | 2012-03-01 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S106) | Boston Scientific Corp | 2012-03-01 |
| LEGOO ENDOVASCULAR OCCLUDER (P110003/S001) | Genzyme Corp. | 2012-03-01 |
| TELIGEN, VENTAK PRIZM HE, CONFIENT, & VARIOUS FAMILIES OF VITALITY ICDS (P960040/S251) | Boston Scientific | 2012-03-01 |
| AXSYM HBSAG (P050049/S010) | Abbott Laboratories, Inc. | 2012-03-01 |
| GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE (N18286/S022) | Pfizer, Inc. | 2012-02-29 |
| CONSULTA & SYNCRA CRT-PS (P010015/S152) | Medtronic, Inc. | 2012-02-29 |
| INSYNC III MARQUIS & INSYNC MAXIMO ICDS (P010031/S287) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM) (P010031/S290) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| TECNIS MULTIFOCAL LENS MODEL ZMA00 (P080010/S007) | Johnson & Johnson Surgical Vision, Inc. | 2012-02-29 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S128) | Boston Scientific Corp | 2012-02-29 |
| FLEXTEND LEADS (P960006/S032) | Boston Scientific | 2012-02-29 |
| EASYTRAK 2 LV-1 & IS-1, EASYTRAK 3 LV-1 & IS-1, AND ACUITY SPIRAL LEADS (P010012/S279) | Boston Scientific Corp | 2012-02-29 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S010) | CooperVision, Inc. | 2012-02-29 |
| ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS (P910073/S100) | Boston Scientific | 2012-02-29 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S013) | Medtronic Vascular | 2012-02-29 |
| GENESYS HTA SYSTEM (P000040/S023) | Axora Medical, Inc. | 2012-02-29 |
| ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD (P910077/S118) | Boston Scientific | 2012-02-29 |
| THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS (P960004/S050) | Boston Scientific | 2012-02-29 |
| MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM) (P980016/S337) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| ACUITY STEERABLE IS-1 LEADS (P050046/S013) | Guidant Corp. | 2012-02-29 |
| VITATRON C20 SR/C60 DR/T20 SR/T60 DR IPGS (P990001/S100) | Medtronic, Inc. | 2012-02-29 |
| REVO MRI (P090013/S050) | Medtronic, Inc. | 2012-02-29 |
| TECNIS 1-PEICE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00, SENSAR 1-PIECE LENS MODEL AAB00 (P980040/S038) | Johnson & Johnson Surgical Vision, Inc. | 2012-02-29 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S112) | Boston Scientific Corp | 2012-02-29 |
| INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS (P980016/S334) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S079) | ABBOTT MEDICAL | 2012-02-29 |
| ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS (P980035/S257) | Medtronic, Inc. | 2012-02-29 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S089) | Cochlear Americas | 2012-02-28 |
| FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE (P050043/S006) | Morris Innovative Research, Inc. | 2012-02-28 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S003) | Roche Diagnostics Corp. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S005) | Roche Diagnostics Corp. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S005) | Roche Diagnostics Corp. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S005) | Roche Diagnostics Corp. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S003) | Roche Diagnostics Corp. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S003) | Roche Diagnostics Corp. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S004) | Roche Diagnostics Corp. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S004) | Roche Diagnostics Corp. | 2012-02-27 |
| SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) (P850035/S034) | Ahp Eos Buyer, Inc. | 2012-02-27 |
| PATHVYSION HER-2 DNA PROBE KIT (P980024/S006) | Abbott Molecular, Inc. | 2012-02-27 |
| ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S004) | Roche Diagnostics Corp. | 2012-02-27 |
| CLEAREAD DETECT (P000041/S011) | Riverain Medical Group | 2012-02-27 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S053) | Spectranetics Corp. | 2012-02-24 |
| ICS 3000 IMPLANT MODULE AUTOMATED TEST (P820076/S025) | Biotronik, Inc. | 2012-02-24 |
| COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S009) | CooperVision, Inc. | 2012-02-24 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S034) | Spectranetics (Philips) | 2012-02-24 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS, 3000/3000TFX AND 3300TFX (P860057/S085) | Edwards Lifesciences, LLC | 2012-02-24 |
| CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S017) | Bayer Pharma AG | 2012-02-24 |
| JUVEDERM HYALURONATE (P050047/S022) | Allergan | 2012-02-24 |
| ELECSYS TOTAL PSA (TPSA) TEST SYSTEM (P990056/S014) | Roche Diagnostics Corp. | 2012-02-24 |
| ELECSYS FREE PSA (FPSA) TEST SYSTEM (P000027/S012) | Roche Diagnostics Corp. | 2012-02-24 |
| STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP (P070008/S024) | Biotronik, Inc. | 2012-02-24 |
| EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S097) | Biotronik, Inc. | 2012-02-24 |
| IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X (P050034/S006) | Samsara Vision, Inc. | 2012-02-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S029) | Ortho-Clinical Diagnostics, Inc. | 2012-02-23 |
| OPTISENSE LEAD MODEL 1999 TUBING (P960013/S070) | ABBOTT MEDICAL | 2012-02-23 |
| COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S008) | CooperVision, Inc. | 2012-02-23 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S021) | Allergan | 2012-02-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR (P030026/S025) | Ortho-Clinical Diagnostics, Inc. | 2012-02-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S022) | Ortho-Clinical Diagnostics, Inc. | 2012-02-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S018) | Ortho-Clinical Diagnostics | 2012-02-23 |
| COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S007) | CooperVision, Inc. | 2012-02-23 |
| VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS (P980023/S046) | Biotronik, Inc. | 2012-02-22 |
| APLIGRAF (P950032/S067) | Organogenesis, Inc. | 2012-02-22 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P100023/S015) | Boston Scientific Corp | 2012-02-22 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 (P100025) | Meridian Bioscience, Inc. | 2012-02-22 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S086) | Boston Scientific Corp | 2012-02-22 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P060008/S046) | Boston Scientific Corp | 2012-02-22 |