| FAMILY OF ICDS (P910023/S258) | ABBOTT MEDICAL | 2011-05-10 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S032) | Intera Oncology | 2011-05-10 |
| MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021/S002) | Medtronic Vascular | 2011-05-09 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S118) | Boston Scientific Corp | 2011-05-09 |
| INTERSTIM II INS (P970004/S109) | Medtronic Neuromodulation | 2011-05-06 |
| INTERSTIM II INS (P080025/S001) | Medtronic Neuromodulation | 2011-05-06 |
| 3058 INTERSTIM II INS (P970004/S111) | Medtronic Neuromodulation | 2011-05-06 |
| SYNERGY/SYNERGY VERSITREL IPS/RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCE (P840001/S182) | Medtronic Neuromodulation | 2011-05-06 |
| ESTEEM (P090018/S001) | Envoy Medical Corporation | 2011-05-06 |
| 3058 INTERSTIM II INS (P080025/S003) | Medtronic Neuromodulation | 2011-05-06 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S031) | Endologix, LLC | 2011-05-06 |
| SYNCHROMED PUMP (P860004/S149) | Medtronic, Inc. | 2011-05-06 |
| LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S044) | Biotronik, Inc. | 2011-05-06 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S034) | Abbott Vascular | 2011-05-06 |
| KINETRA/ACTIVA PC/ACTIVE SC/RC INS (P960009/S112) | Medtronic, Inc. | 2011-05-06 |
| EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S095) | Biotronik, Inc. | 2011-05-06 |
| ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S047) | Ahp Eos Buyer, Inc. | 2011-05-06 |
| ANCHORING SLEEVE KIT (P030036/S022) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| CADENCE FAMILY OF ICDS (P910023/S260) | ABBOTT MEDICAL | 2011-05-05 |
| REPEL-CV (P070005/S002) | Pathfinder Cell Therapy, Inc. | 2011-05-05 |
| CONTAK RENEWAL TR (P030005/S075) | Guidant Corp. | 2011-05-05 |
| ISOFLEX MODEL 1646T & MODEL 1948T (OPTIM) LOW VOLTAGE LEADS (P960030/S033) | ABBOTT MEDICAL | 2011-05-05 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S018) | Roche Molecular Systems, Inc. | 2011-05-05 |
| PROTECTA XT/PROTECTA DEVICES (P010031/S245) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| CARPENTIER-EDWARDS PORCINE AORTIC/PORCINE MITRAL BIOPROSTHESIS (P870056/S043) | Edwards Lifesciences, LLC | 2011-05-05 |
| GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S035) | Gynecare, Inc. | 2011-05-05 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S185) | ABBOTT MEDICAL | 2011-05-05 |
| SYNCRA CRT-P/CONSULTA CRT-P (P010015/S113) | Medtronic, Inc. | 2011-05-05 |
| ADVISA DR (P980035/S215) | Medtronic, Inc. | 2011-05-05 |
| CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S027) | Edwards Lifesciences, LLC | 2011-05-05 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S039) | Edwards Lifesciences, LLC | 2011-05-05 |
| REVO MRI (P090013/S015) | Medtronic, Inc. | 2011-05-05 |
| VISIAN ICL (P030016/S019) | STAAR Surgical Company | 2011-05-05 |
| PROTECTA/PROTECTA XT CRT-DS (P010031/S246) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL/RSR/MAGNA/MAGNA EASE/MITRAL/MAGNA MITRAL AORTIC PERICARDIAL BIOPROSTHESIS (P860057/S078) | Edwards Lifesciences, LLC | 2011-05-05 |
| ADVISA DR (P980035/S213) | Medtronic, Inc. | 2011-05-05 |
| PROTECTA DR/VR/XT DR/VR (P980016/S292) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| ATTAIN ABILITY PLUS MODEL 4296 (P080006/S022) | Medtronic, Inc. | 2011-05-05 |
| PROTECTA CRT-D/PROTECTA XT CRT-D (P010031/S243) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S008) | Hologic, Inc. | 2011-05-05 |
| PROTECTA DR/VR/XT DR/XT VR (P980016/S290) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| PROTECTA DR/VR/XT DR/XT VR (P980016/S289) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| CONSULTA/SYNCRA CRT-PS (P010015/S114) | Medtronic, Inc. | 2011-05-05 |
| CONSULTA/SYNCRA CRT-P (P010015/S115) | Medtronic, Inc. | 2011-05-05 |
| PROTECTA DR/VR/XT DR/VR (P980016/S291) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| PROTECTA/PROTECTA XT CRT-DS (P010031/S244) | Medtronic Cardiac Rhythm Disease Management | 2011-05-05 |
| ADVISA DR (P980035/S214) | Medtronic, Inc. | 2011-05-05 |
| EXPRESS & EXPRESS 2 CORONARY STENT SYSTEMS (P020009/S073) | Boston Scientific Scimed, Inc. | 2011-05-04 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S069) | Boston Scientific Corp | 2011-05-04 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA (P030016/S020) | STAAR Surgical Company | 2011-05-04 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S019) | Medtronic Sofamor Danek, Inc. | 2011-05-04 |
| T-SPOT TB TEST (P070006/S005) | Oxford Immunotec, Ltd. | 2011-05-04 |
| SOLETRA/KINETRA/ACTIVA PC/SC/RC INS (P960009/S114) | Medtronic, Inc. | 2011-05-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090007/S002) | Roche Diagnostics Corp. | 2011-05-04 |
| STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S031) | Starr Surgical Co. | 2011-05-04 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S013) | Roche Diagnostics Corp. | 2011-05-04 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S067) | Abbott Vascular, Inc. | 2011-05-04 |
| INTERSTIM/INTERSTIM II NEUROSTIMULATOR (P970004/S110) | Medtronic Neuromodulation | 2011-05-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090009/S002) | Roche Diagnostics Corp. | 2011-05-04 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S020) | Boston Scientific Corp | 2011-05-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY (P090008/S002) | Roche Diagnostics Corp. | 2011-05-04 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S071) | Boston Scientific Scimed, Inc. | 2011-05-04 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S008) | Roche Diagnostics Corp. | 2011-05-04 |
| RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/ITREL 3/SYNERGY/SYNERGY VERSITREL INS (P840001/S183) | Medtronic Neuromodulation | 2011-05-04 |
| INTERSTIM/INTERSTIM II NEUROSTIMULATOR (P080025/S002) | Medtronic Neuromodulation | 2011-05-04 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S006) | OraSure Technologies, Inc. | 2011-05-04 |
| CARELINK HOME MONITOR AND CARDIOSIGHT MONITOR (P890003/S209) | Medtronic, Inc. | 2011-05-04 |
| RELIANCE LEADS (P910073/S093) | Boston Scientific | 2011-05-03 |
| FAMILY OF CRT-DS (P030054/S186) | ABBOTT MEDICAL | 2011-05-03 |
| FAMILY OF ICDS (P910023/S261) | ABBOTT MEDICAL | 2011-05-03 |
| FAMILY OF CRT-PS (P880086/S201) | ABBOTT MEDICAL | 2011-05-03 |
| FAMILY OF PACEMAKERS (P030035/S081) | ABBOTT MEDICAL | 2011-05-03 |
| ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL (P930014/S045) | Alcon Laboratories, Inc. | 2011-05-03 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S029) | Biomet Manufacturing Corp | 2011-05-03 |
| VALIANT THORACIC STENT GRAFT SYSTEM (P100040/S001) | Medtronic Vascular | 2011-05-02 |
| BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (CAROTID WALLSTENT ENDOPROSTHESIS) (P050019/S007) | Boston Scientific Corp | 2011-05-02 |
| VENTAK/VENTAK P/VENTAK P2 FAMILIES (P830060/S068) | Boston Scientific | 2011-04-29 |
| THINLINE/FINELINE FAMILIES (P960004/S049) | Boston Scientific | 2011-04-29 |
| FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE (P020045/S038) | Medtronic Cryocath, LP | 2011-04-29 |
| SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND FAMILIES (P960006/S030) | Boston Scientific | 2011-04-29 |
| UNIVERSAL CRYOCONSOLE (P020045/S036) | Medtronic Cryocath, LP | 2011-04-29 |
| ENDOTAK RELIANCE (P910073/S095) | Boston Scientific | 2011-04-29 |
| SPOT-LIGHT HER2 CISH KIT (P050040/S002) | Invitrogen Corporation | 2011-04-29 |
| VNS THERAPY DEMIPULSE/DEMIPULSE DUO GENERATORS (P970003/S125) | LivaNova USA, Inc. | 2011-04-29 |
| DELTA/VISTA FAMILIES (P840068/S049) | Boston Scientific | 2011-04-29 |
| AKREOS POSTERIOR CHAMBER INTRACULAR LENS (P060022/S008) | Bausch & Lomb, Inc. | 2011-04-29 |
| TETRAFILCON A (N17679/S035) | CooperVision, Inc. | 2011-04-29 |
| VIGOR DR/SR/DISCOVERY/MERIDIAN FAMILIES (P940031/S071) | Boston Scientific | 2011-04-29 |
| SELUTE LEAD FAMILY (P950001/S022) | Boston Scientific | 2011-04-29 |
| VENTAK/VENTAK P/VENTAK P2 FAMILIES (P890061/S019) | Boston Scientific | 2011-04-29 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S005) | Medtronic, Inc. | 2011-04-29 |
| BALLOON CATHETER (P100010/S009) | Medtronic Cryocath, LP | 2011-04-29 |
| VENTAK AV/VENTAK PRIZM DR/VR/VITALITY/CONFIENT/LIVIAN FAMILIES (P960040/S243) | Boston Scientific | 2011-04-29 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S113) | Medtronic, Inc. | 2011-04-29 |
| VENTAK PRX/MINI FAMILIES (P910077/S113) | Boston Scientific | 2011-04-29 |
| UROLOGIX TARGIS SYSTEM (P970008/S056) | Urologix, LLC | 2011-04-29 |
| VENTAK/VENTAK P/VENTAK P2 FAMILIES (P930035/S020) | Boston Scientific | 2011-04-29 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S066) | Abbott Vascular, Inc. | 2011-04-29 |
| LATITUDE COMMUNICATORS (P910077/S112) | Boston Scientific | 2011-04-29 |
| ACUITY STEERABLE FAMILY (P050046/S010) | Guidant Corp. | 2011-04-29 |