| INSYNC 3 CRT-P (P010015/S092) | Medtronic, Inc. | 2010-08-02 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S004) | Bio-Rad Laboratories, Inc. | 2010-08-02 |
| ENRHYTHM IPG (P980035/S173) | Medtronic, Inc. | 2010-08-02 |
| VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD (P050023/S032) | Biotronik, Inc. | 2010-07-30 |
| INTRAOCULAR LENS (P080004/S005) | Hoya Surgical Optics, Inc. | 2010-07-30 |
| REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM (P030022/S016) | Smith & Nephew, Inc. | 2010-07-30 |
| STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS (P070008/S016) | Biotronik, Inc. | 2010-07-30 |
| REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C (P070009/S008) | Obtech Medical GmbH | 2010-07-30 |
| EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX (P950037/S082) | Biotronik, Inc. | 2010-07-30 |
| KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS (P980023/S041) | Biotronik, Inc. | 2010-07-30 |
| LEXOS DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS (P000009/S039) | Biotronik, Inc. | 2010-07-30 |
| STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S027) | Starr Surgical Co. | 2010-07-29 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATORS (P970004/S090) | Medtronic Neuromodulation | 2010-07-29 |
| RESTOR IMPLANTABLE NEUROSTIMULATORS (P840001/S157) | Medtronic Neuromodulation | 2010-07-29 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENS (P030016/S015) | STAAR Surgical Company | 2010-07-29 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S088) | Medtronic, Inc. | 2010-07-29 |
| SYNCHROMED PROGRAMMABLE DRUG PUMPS (P860004/S135) | Medtronic, Inc. | 2010-07-29 |
| CONCERTO/CONSULTA & MAXIMO II CRT-DS (P010031/S207) | Medtronic Cardiac Rhythm Disease Management | 2010-07-28 |
| BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S004) | Boston Scientific Corp | 2010-07-28 |
| POWERLINK SYSTEM FOR AAA (P040002/S026) | Endologix, LLC | 2010-07-28 |
| HANCOCK II PORCINE BIOPROSTHESIS MODELS T505 & T510 (P980043/S027) | Medtronic, Inc. | 2010-07-28 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S026) | Medtronic Heart Valves | 2010-07-28 |
| BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS (P860019/S258) | Scimed Life Systems, Inc. | 2010-07-28 |
| HANCOCK LOW POROSITY VALVED CONDUIT MODEL 105 (P870078/S010) | Medtronic, Inc. | 2010-07-28 |
| ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S178) | Medtronic, Inc. | 2010-07-28 |
| DA+C & DA+T SERIES (P990001/S071) | Medtronic, Inc. | 2010-07-28 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE (P990004/S018) | Ferrosan Meidcal Devices A/S | 2010-07-28 |
| ENRHYTHM/RELIA/ADAPTA/VERSA/SENSIA IPGS (P980035/S176) | Medtronic, Inc. | 2010-07-28 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S004) | Hologic, Inc. | 2010-07-28 |
| SECURA DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS (P980016/S251) | Medtronic Cardiac Rhythm Disease Management | 2010-07-28 |
| APLIGRAF (P950032/S058) | Organogenesis, Inc. | 2010-07-27 |
| VIBRANT SOUNDBRIDGE SYSTEM (P990052/S022) | Med-El Elektromedizinische Gerate GmbH | 2010-07-27 |
| ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S002) | Boston Scientific Corp | 2010-07-27 |
| LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S017) | Alcon Laboratories, Inc. | 2010-07-26 |
| REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER (P070009/S010) | Obtech Medical GmbH | 2010-07-26 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S045) | Med-El Corp. | 2010-07-26 |
| MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II (P980016/S249) | Medtronic Cardiac Rhythm Disease Management | 2010-07-23 |
| KAPPA 600/700/650/800/900/RELIA/ENPULSE/ADAPTA/VERSA/SENSIA IPGS (P980035/S175) | Medtronic, Inc. | 2010-07-23 |
| TRANSVENE DEFRIBRILLAITON LEAD (P900061/S090) | Medtronic Cardiac Rhythm Disease Management | 2010-07-23 |
| CONCERTO/CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S205) | Medtronic Cardiac Rhythm Disease Management | 2010-07-23 |
| CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S204) | Medtronic Cardiac Rhythm Disease Management | 2010-07-23 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S039) | Abbott Vascular, Inc. | 2010-07-23 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S248) | Medtronic Cardiac Rhythm Disease Management | 2010-07-23 |
| KAPPA 400 SR IPG (P970012/S070) | Medtronic, Inc. | 2010-07-23 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S012) | Stryker Corp. | 2010-07-23 |
| TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S037) | Boston Scientific Corp | 2010-07-22 |
| VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER (N18033/S047) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2010-07-22 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S062) | Cochlear Americas | 2010-07-22 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910077/S105) | Boston Scientific | 2010-07-22 |
| TAXUS LIBERTE LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S038) | Boston Scientific Corp | 2010-07-22 |
| H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM (P940016/S013) | B. Braun Avitum AG | 2010-07-22 |
| CADENCE FAMILY OF ICDS (P910023/S238) | ABBOTT MEDICAL | 2010-07-21 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S030) | Hologic, Inc. | 2010-07-21 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S005) | Hologic, Inc. | 2010-07-21 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S156) | ABBOTT MEDICAL | 2010-07-21 |
| RESTORE/ITREL 3/SYNERGY FAMILIES OF IMPLANTABLE NEUROSTIMULATORS (P840001/S156) | Medtronic Neuromodulation | 2010-07-20 |
| MULTI-LINK/VISION/MINI VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S021) | Abbott Vascular | 2010-07-20 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S089) | Medtronic Neuromodulation | 2010-07-20 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMPS (P860004/S134) | Medtronic, Inc. | 2010-07-20 |
| SIDE CATHETER ACCESS PORT KITS (P990034/S019) | Medtronic, Inc. | 2010-07-20 |
| MULTI-LINK ZETA CORONARY STENT SYSTEMS (CSS) (P970020/S056) | Abbott Vascular, Inc. | 2010-07-20 |
| XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S040) | Abbott Vascular, Inc. | 2010-07-20 |
| PEPGEN P-15 FLOW (P990033/S017) | Ceramed Corp. | 2010-07-20 |
| ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P960009/S087) | Medtronic, Inc. | 2010-07-20 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S100) | Boston Scientific Corp | 2010-07-19 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S102) | Boston Scientific Corp | 2010-07-19 |
| ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S174) | Medtronic, Inc. | 2010-07-16 |
| VITATRON (P990001/S063) | Medtronic, Inc. | 2010-07-16 |
| ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S012) | Ortho-Clinical Diagnostics | 2010-07-16 |
| SIGMA/MEDTRONIC 350 SERIES/ENRHYTHM IPG/ADAPTA/SENSIA/RELIA/VERSA (P980035/S160) | Medtronic, Inc. | 2010-07-16 |
| HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT (P000044/S023) | Ortho-Clinical Diagnostics, Inc. | 2010-07-16 |
| CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM (P030042/S002) | Microport Orthopedics, Inc. | 2010-07-16 |
| ANTI-HBC REAGENT PACK AND CALIBRATOR (P030026/S019) | Ortho-Clinical Diagnostics, Inc. | 2010-07-16 |
| ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S017) | Ortho-Clinical Diagnostics, Inc. | 2010-07-16 |
| COROX OTW STEROID LV LEAD MONITORING (COSMO) (P050023/S035) | Biotronik, Inc. | 2010-07-16 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR (P000014/S020) | Ortho-Clinical Diagnostics, Inc. | 2010-07-16 |
| INSYNC III (IPG) (P010015/S081) | Medtronic, Inc. | 2010-07-16 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/ENTRUST/VIRTUOSO (P980016/S230) | Medtronic Cardiac Rhythm Disease Management | 2010-07-16 |
| UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH (P970008/S051) | Urologix, LLC | 2010-07-16 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR VIRTUOSO ICDS (P980016/S247) | Medtronic Cardiac Rhythm Disease Management | 2010-07-16 |
| CONSULTA/MAXIMO II/CONCERTO II/CONCERTO CRT-DS (P010031/S189) | Medtronic Cardiac Rhythm Disease Management | 2010-07-16 |
| CONCERTO II/CONSULTA/MAXIMO II CRT-DS/CONCERTO (P010031/S203) | Medtronic Cardiac Rhythm Disease Management | 2010-07-16 |
| GENESYS HTA SYSTEM (P000040/S015) | Axora Medical, Inc. | 2010-07-16 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S191) | ABBOTT MEDICAL | 2010-07-16 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S169) | Medtronic, Inc. | 2010-07-15 |
| DEMA IPG/C & T SERIES IPGS (P990001/S069) | Medtronic, Inc. | 2010-07-15 |
| DURATA FAMILY OF LEADS (P950022/S071) | ABBOTT MEDICAL | 2010-07-15 |
| ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN (P900061/S089) | Medtronic Cardiac Rhythm Disease Management | 2010-07-15 |
| CADENCE FAMILY OF ICDS (P910023/S237) | ABBOTT MEDICAL | 2010-07-15 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S190) | ABBOTT MEDICAL | 2010-07-15 |
| KAPPA 400 DR/SR IPG (P970012/S069) | Medtronic, Inc. | 2010-07-15 |
| SPECTRANETICS SLS II LASER SHEATH (P960042/S017) | Spectranetics (Philips) | 2010-07-15 |
| DEXCOM SEVEN AND SEVEN PLUS SYSTEM (P050012/S025) | Dexcom, Inc. | 2010-07-15 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT & ZENITH RENU AAA ANCILLARY GRAFT WITH Z-TRAK INTRODUCTION SYSTEM (P020018/S036) | Cook, Inc. | 2010-07-15 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P850051/S073) | Medtronic, Inc. | 2010-07-15 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S062) | Terumo Medical Corporation | 2010-07-15 |
| ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S015) | Anika Therapeutics, Inc. | 2010-07-15 |
| CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S199) | Medtronic Cardiac Rhythm Disease Management | 2010-07-15 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S004) | Boston Scientific Corporation | 2010-07-15 |
| SOF-SENSOR GLUCOSE SENSOR (P980022/S079) | Medtronic Minimed | 2010-07-15 |