| TRILOGY AB ACETABULAR SYSTEM PACKAGE INSERT (P040048/S014) | Zimmer, Inc. | 2011-06-02 |
| CONTRAK RENEWAL TR (P030005/S076) | Guidant Corp. | 2011-06-02 |
| ADAPTA, VERSA, SENSIA, RELIA IPGS (P980035/S227) | Medtronic, Inc. | 2011-06-02 |
| ARCHITECT AUSAB (P050051/S012) | Abbott Laboratories, Inc. | 2011-06-01 |
| ARCHITECT CORE-M (P060035/S008) | Abbott Laboratories | 2011-06-01 |
| ARCHITECT HBSAG/CONFIMATORY (P060007/S014) | Abbott Laboratories | 2011-06-01 |
| ARCHITECT CORE (P080023/S008) | Abbott Laboratories | 2011-06-01 |
| UROVYSION BLADDER CANCER KIT ASSAY (P030052/S007) | Abbott Molecular | 2011-06-01 |
| ARCHITECT ANTI-HCV (P050042/S012) | Abbott Laboratories, Inc. | 2011-06-01 |
| SURGIFOAM HEMOSTATIC MATRIX KIT (P990004/S017) | Ferrosan Meidcal Devices A/S | 2011-05-31 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S011) | Boston Scientific Corporation | 2011-05-31 |
| MACROPLASTIQUE IMPLANTS (P040050/S008) | Uroplasty, LLC | 2011-05-27 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S032) | Alcon Research, Ltd. | 2011-05-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| VISCOAT/DISCOVISC/DUOVISC (P840064/S044) | Alcon Laboratories | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| REVO MRI SURESCAN PACING SYSTEM (P090013/S012) | Medtronic, Inc. | 2011-05-27 |
| REVO MRI SURESCAN PACING SYSTEM (P090013/S013) | Medtronic, Inc. | 2011-05-27 |
| GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S016) | Lynch Biologics, LLC | 2011-05-27 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S019) | Hologic, Inc. | 2011-05-27 |
| CARELINK MONITOR 2490G (P890003/S220) | Medtronic, Inc. | 2011-05-27 |
| SOLESTA INJECTABLE GEL (P100014) | Palette Life Sciences | 2011-05-27 |
| PROTECTA & PROTECTA XT CRT-DS (P010031/S249) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP (P070008/S023) | Biotronik, Inc. | 2011-05-26 |
| UROVYSION BLADDER CANCER KIT (P030052/S006) | Abbott Molecular | 2011-05-26 |
| PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S012) | Medtronic Vascular, Inc. | 2011-05-26 |
| LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S045) | Biotronik, Inc. | 2011-05-26 |
| ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM/ADVISA DR/KAPPA 700/800/900/SIGMA/MEDTRONIC 350 IPG SERIES/ENPULSE/AT500 SYSTEMS IPGS (P980035/S222) | Medtronic, Inc. | 2011-05-26 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S018) | Smith & Nephew, Inc. | 2011-05-26 |
| EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S096) | Biotronik, Inc. | 2011-05-26 |
| CONSULTA & SYNCRA CRT-P (P010015/S119) | Medtronic, Inc. | 2011-05-26 |
| REVO MRI IPG (P090013/S021) | Medtronic, Inc. | 2011-05-26 |
| KAPPA 400 DR/SR IPG (P970012/S084) | Medtronic, Inc. | 2011-05-26 |
| DEMA IPGS/C & T SERIES IPGS (P990001/S088) | Medtronic, Inc. | 2011-05-26 |
| MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S022) | Medtronic, Inc. | 2011-05-26 |
| ADVISA (P980035/S219) | Medtronic, Inc. | 2011-05-26 |
| REVO MRI (P090013/S019) | Medtronic, Inc. | 2011-05-26 |
| PROTECTA + PROTECTA XT (P980016/S295) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D/PROTECTA/XT CRT-D (P010031/S253) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| QUANTIFERON-TB GOLD IN-TUBE (P010033/S017) | Qiagen | 2011-05-26 |
| SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/PROTECTA DR/VR/PTOTECTA XT DR/VR/INSYNC II/III MARQUIS (P980016/S299) | Medtronic Cardiac Rhythm Disease Management | 2011-05-26 |
| LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS (P000009/S045) | Biotronik, Inc. | 2011-05-26 |
| LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S044) | Biotronik, Inc. | 2011-05-26 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S023) | Coloplast Corp. | 2011-05-25 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S003) | Medtronic Vascular | 2011-05-25 |
| ELECSYS FREE PSA IMMUNOASSAY (P000027/S010) | Roche Diagnostics Corp. | 2011-05-24 |
| XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S054) | Abbott Vascular, Inc. | 2011-05-24 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S026) | Roche Molecular Systems, Inc. | 2011-05-24 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S070) | Boston Scientific Corp | 2011-05-24 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S012) | Roche Diagnostics Corp. | 2011-05-24 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S007) | Medtronic Cryocath, LP | 2011-05-23 |
| PROTECTA DR/VR/PROTECTA XT DR/VR (P980016/S296) | Medtronic Cardiac Rhythm Disease Management | 2011-05-23 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S033) | Intera Oncology | 2011-05-23 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S036) | Abbott Vascular, Inc. | 2011-05-23 |
| CONSULTA/SYNCRA CRT-PS (P010015/S120) | Medtronic, Inc. | 2011-05-23 |
| ATTAIN ABILITY PLUS/STRAIGHT (P080006/S024) | Medtronic, Inc. | 2011-05-23 |
| PROTECTA/PROTECTA XT CRT-DS (P010031/S250) | Medtronic Cardiac Rhythm Disease Management | 2011-05-23 |
| ADVISA DR (P980035/S220) | Medtronic, Inc. | 2011-05-23 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S055) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2011-05-20 |
| MEDTRONIC PARADIGM CONTINUOUS GLUCOSE MONITORING SYSTEMS (P980022/S097) | Medtronic Minimed | 2011-05-20 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S006) | Integra LifeSciences Corporation | 2011-05-20 |
| ARCHITECT CORE (P080023/S005) | Abbott Laboratories | 2011-05-20 |
| AXSYM AFP (P820060/S026) | Abbott Laboratories | 2011-05-20 |
| AXSYM AUSAB (P060003/S007) | Abbott Laboratories, Inc. | 2011-05-20 |
| AXSYM HBSAG/CONFIRMATORY (P050049/S005) | Abbott Laboratories, Inc. | 2011-05-20 |
| AXSYM ANTI-HCV (P970027/S011) | Abbott Laboratories | 2011-05-20 |
| ARCHITECT CORE-M (P060035/S005) | Abbott Laboratories | 2011-05-20 |
| AXSYM CORE-M (P060009/S003) | Abbott Laboratories, Inc. | 2011-05-20 |
| VNS THERAPY SYSTEM GENERATORS (P970003/S126) | LivaNova USA, Inc. | 2011-05-20 |
| AXSYM TOTAL PSA (P910007/S022) | Abbott Laboratories | 2011-05-20 |
| AXSYM FREE PSA (P980007/S014) | Abbott Laboratories | 2011-05-20 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S018) | Vistakon, Division of Johnson & Johnson Vision Car | 2011-05-20 |
| AXSYM CORE (P060012/S005) | Abbott Laboratories, Inc. | 2011-05-20 |
| ADAPTA/RELIA/SENSIA/VERSA (P980035/S209) | Medtronic, Inc. | 2011-05-19 |
| ATTAIN STARFIX (P060039/S025) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S221) | Medtronic, Inc. | 2011-05-19 |
| BIOMET EBI BONE HEALING SYSTEM (P790002/S026) | Ahp Eos Buyer, Inc. | 2011-05-19 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S031) | Medtronic, Inc. | 2011-05-19 |
| ADAPTOR:EPG SAFETY CABLE (P820003/S105) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| TRANSVENOUS BIPOLAR PACING LEAD (P960006/S029) | Boston Scientific | 2011-05-19 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II (P980016/S297) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S251) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| REVO MRI IPG (P090013/S017) | Medtronic, Inc. | 2011-05-19 |
| VITATRON DA+ C & T SERIES (P990001/S087) | Medtronic, Inc. | 2011-05-19 |
| ENRHYTHM IPG (P980035/S218) | Medtronic, Inc. | 2011-05-19 |
| MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX; ML-8 (P020047/S032) | Abbott Vascular | 2011-05-19 |
| 350 SERIES/ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA (P980035/S221) | Medtronic, Inc. | 2011-05-19 |
| ATTAIN/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-P (P010015/S121) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+ (P930039/S052) | Medtronic, Inc. | 2011-05-19 |
| CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS+ (P830061/S063) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP (P900061/S102) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| CATH RF CONDUCTR/5 MM 8FR/RF MC 078 6022/CONTACTR CATHETER 7 FR 5MM/RF CONDUCTR MC SELF-REFERENCE CATHETER/RF ENHANCR II (P930029/S029) | Medtronic, Inc. | 2011-05-19 |
| Y ADAPTOR/EXTENDER KIT/DF-1 CONNECTOR PORT PIN PLUG/ LEAD ADAPTOR/SPRINT/SPRINT QUATTRO/QUATTRO LEAD/SUBCUTANEOUS LEAD (P920015/S076) | Medtronic, Inc. | 2011-05-19 |
| XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S060) | Abbott Vascular, Inc. | 2011-05-19 |
| ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT (P080006/S025) | Medtronic, Inc. | 2011-05-19 |
| CORDIS EXOSEAL VASCULAR CLOSURE DEVICE (P100013) | Cordis US Corporation | 2011-05-19 |
| DEXCOM SEVEN & SEVEN PLUS SYSTEM (P050012/S033) | Dexcom, Inc. | 2011-05-19 |
| SELECTSECURE (P030036/S030) | Medtronic Cardiac Rhythm Disease Management | 2011-05-19 |
| TRANSVENE CS/SVC LEAD (P980050/S061) | Medtronic, Inc. | 2011-05-19 |
| REVO MRI (P090013/S020) | Medtronic, Inc. | 2011-05-19 |