| MMT-7002 & MMT-7003 GLUCOSE SENSORS (P980022/S062) | Medtronic Minimed | 2009-10-29 |
| ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S034) | Alcon Laboratories, Inc. | 2009-10-29 |
| FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM (P050020/S008) | Abbott Laboratories | 2009-10-29 |
| ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S040) | Medtronic, Inc. | 2009-10-29 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S061) | ABBOTT MEDICAL | 2009-10-28 |
| LEAD FIXATION SLEEVE (P070008/S013) | Biotronik, Inc. | 2009-10-28 |
| TELIGEN ICDS (P960040/S205) | Boston Scientific | 2009-10-28 |
| COGNIS CRT-DS (P010012/S220) | Boston Scientific Corp | 2009-10-28 |
| AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S180) | ABBOTT MEDICAL | 2009-10-28 |
| SYMPHONY SR/DR, RHAPSODY SR/DR, REPLY SR/DR, AND ESPRIT SR/DR PACEMAKERS (P950029/S047) | MicroPort CRM USA, Inc. | 2009-10-28 |
| MMT-7002 & MMT-7003 GLUCOSE SENSORS (P980022/S060) | Medtronic Minimed | 2009-10-28 |
| CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S156) | Medtronic Cardiac Rhythm Disease Management | 2009-10-27 |
| PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE (P060027/S011) | MicroPort CRM USA, Inc. | 2009-10-27 |
| VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II DR/VR (P980016/S195) | Medtronic Cardiac Rhythm Disease Management | 2009-10-27 |
| ACTIVA PC NEUROSTIMULATOR (P960009/S071) | Medtronic, Inc. | 2009-10-27 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S073) | Medtronic Neuromodulation | 2009-10-26 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM (P070027/S012) | Medtronic Vascular | 2009-10-23 |
| CRYSTALENS MODELS AT50AO AND AT52AO ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S021) | Bausch & Lomb, Inc. | 2009-10-23 |
| ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM (P990020/S037) | Medtronic Vascular | 2009-10-23 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S011) | Integra LifeSciences Corporation | 2009-10-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI (P000044/S020) | Ortho-Clinical Diagnostics, Inc. | 2009-10-23 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S011) | Stryker Corp. | 2009-10-23 |
| TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM (P070007/S012) | Medtronic Vascular | 2009-10-23 |
| T-SPOT .TB TEST (P070006/S002) | Oxford Immunotec, Ltd. | 2009-10-22 |
| VISTAKON (ETAFILCON A) CONTACT LENS (N18033/S043) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2009-10-22 |
| COAPTITE INJECTABLE IMPLANT (P040047/S015) | Merz North America, Inc. | 2009-10-22 |
| CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S220) | ABBOTT MEDICAL | 2009-10-22 |
| HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P070008/S012) | Biotronik, Inc. | 2009-10-22 |
| HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P050023/S026) | Biotronik, Inc. | 2009-10-22 |
| UROLOGIX TARGIS SYSTEM (P970008/S046) | Urologix, LLC | 2009-10-22 |
| HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P950037/S073) | Biotronik, Inc. | 2009-10-22 |
| HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P000009/S036) | Biotronik, Inc. | 2009-10-22 |
| COGNIS/LIVIAN/CONTAK RENEWAL/CONTAK RENEWAL 3 RF (P010012/S219) | Boston Scientific Corp | 2009-10-21 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S015) | Medtronic Sofamor Danek, Inc. | 2009-10-21 |
| PERCLOSE PROGLIDE SUTURE MEDIATED SYSTEM/PERCLOSE A T 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S067) | Abbott Vascular, Inc. | 2009-10-21 |
| TELIGEN/CONFIENT/VITALITY PULSE GENERATORS (P960040/S204) | Boston Scientific | 2009-10-21 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S033) | Medtronic Sofamor Danek USA, Inc. | 2009-10-21 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S003) | Biomet Microfixation, Inc. | 2009-10-21 |
| INFUSE BONE GRAFT (P000054/S022) | Medtronic Sofamor Danek USA, Inc. | 2009-10-21 |
| XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S025) | Abbott Vascular, Inc. | 2009-10-21 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S026) | Abbott Vascular, Inc. | 2009-10-21 |
| INFUSE BONE GRAFT (P050053/S012) | Medtronic, Inc. | 2009-10-21 |
| CARDIOGENESIS TMR SYSTEM (P970029/S015) | Cryolife, Inc. | 2009-10-20 |
| ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040/S002) | Siemens Healthcare Diagnostics | 2009-10-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT (P000044/S022) | Ortho-Clinical Diagnostics, Inc. | 2009-10-20 |
| ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS (P040004/S002) | Siemens Healthcare Diagnostics | 2009-10-20 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S001) | Hologic, Inc. | 2009-10-20 |
| ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S038) | Medtronic, Inc. | 2009-10-19 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S025) | Hologic, Inc. | 2009-10-16 |
| ON-X PROSTHETIC HEART VALVE (P000037/S016) | On-X Life Technologies, Inc. | 2009-10-16 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S019) | Cordis US Corporation | 2009-10-16 |
| CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S008) | Alcon Laboratories | 2009-10-15 |
| SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS (P840001/S141) | Medtronic Neuromodulation | 2009-10-15 |
| DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS (P960009/S070) | Medtronic, Inc. | 2009-10-15 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S029) | Alcon Research, Ltd. | 2009-10-15 |
| INTERSTIM FAMILY OF NEUROSTIMULATION LEADS (P970004/S075) | Medtronic Neuromodulation | 2009-10-15 |
| VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S041) | Alcon Laboratories | 2009-10-15 |
| CADENCE ICDS (P910023/S218) | ABBOTT MEDICAL | 2009-10-14 |
| EPIC HF CRT-DS (P030054/S136) | ABBOTT MEDICAL | 2009-10-14 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S024) | Abbott Vascular, Inc. | 2009-10-14 |
| COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S005) | Roche Molecular Systems, Inc. | 2009-10-13 |
| PREVELLE SILK & HYLAN B GEL (P030032/S009) | Genzyme Biosurgery | 2009-10-09 |
| DURASEAL DURAL SEALANT SYSTEM (P040034/S013) | Integra LifeSciences Corporation | 2009-10-09 |
| CYPHER SIROLIMUS-ELUTING STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S068) | Cordis Corp. | 2009-10-09 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S005) | Bausch & Lomb, Inc. | 2009-10-08 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S072) | Medtronic, Inc. | 2009-10-08 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S142) | Medtronic, Inc. | 2009-10-08 |
| ADAPTA/VERSA/SENSIA IPG FAMILY/RELIA IPG (P980035/S141) | Medtronic, Inc. | 2009-10-08 |
| MAXUM SYSTEM (P010023/S002) | Ototronix, LLC | 2009-10-08 |
| KAPPA 400 DR/SR IPG (P970012/S057) | Medtronic, Inc. | 2009-10-08 |
| ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S008) | Spectranetics Corp. | 2009-10-08 |
| VIDAS FREE PSA RT ASSAY (P080008) | bioMerieux, Inc. | 2009-10-08 |
| MAXIMO II CRT-D/CONSULTA CRT-D/CONCERTO II CRT-D (P010031/S164) | Medtronic Cardiac Rhythm Disease Management | 2009-10-08 |
| CLARITY DDDR, CLARITY SSIR, DIAMOND III, RUBY III, TOPAZ III, JADE III, VITA 2 DDDR, C-SERIES, AND T-SERIES FAMILY OF IP (P990001/S056) | Medtronic, Inc. | 2009-10-08 |
| ADAPTA/VERSA/SENSIA (P980035/S143) | Medtronic, Inc. | 2009-10-08 |
| MARQUIS/MAXIMO/INSTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S204) | Medtronic Cardiac Rhythm Disease Management | 2009-10-08 |
| STARCLOSURE SE VASCULAR CLOSURE SYSTEM (P050007/S022) | Abbott Vascular Devices | 2009-10-08 |
| INSYNC/INSYNC MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/CONCERTO/II CRT-D/MAXIMO II/CONSULTA CRT-D (P010031/S165) | Medtronic Cardiac Rhythm Disease Management | 2009-10-08 |
| MEDTRONIC MODEL 2490C CARELINK MONITORS (P890003/S174) | Medtronic, Inc. | 2009-10-08 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049/S001) | LeMaitre Vascular, Inc. | 2009-10-08 |
| MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD (P980016/S203) | Medtronic Cardiac Rhythm Disease Management | 2009-10-08 |
| BIRMINGHAM HIP RESURFACING SYSTEM, REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P040033/S012) | Smith & Nephew, Inc. | 2009-10-07 |
| REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM (P030022/S012) | Smith & Nephew, Inc. | 2009-10-07 |
| REALIZE ADJUSTABLE GASTRIC BAND-C (P070009/S006) | Obtech Medical GmbH | 2009-10-06 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S134) | ABBOTT MEDICAL | 2009-10-02 |
| BLAZER PRIME HTD CARDIAC ABLATION CATHETERS (P920047/S039) | Boston Scientific Corp | 2009-10-02 |
| CADENCE FAMILY OF ICDS (P910023/S217) | ABBOTT MEDICAL | 2009-10-02 |
| SURGIFLO HEMOSTATIC MATRIX KIT (P990004/S016) | Ferrosan Meidcal Devices A/S | 2009-10-02 |
| SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES (P040021/S011) | ABBOTT MEDICAL | 2009-10-02 |
| EXOGEN BONE HEALING SYSTEM (P900009/S031) | Bioventus, LLC | 2009-10-02 |
| THINPREP PROCESSOR 2000/3000 (P950039/S020) | Hologic, Inc. | 2009-10-02 |
| BLAZER PRIME XP CARDIAC ABLATION CATHETERS (P020025/S020) | Boston Scientific | 2009-10-02 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S011) | Allergan, Inc. | 2009-10-02 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S010) | Stryker Corp. | 2009-10-01 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S001) | Abbott Vascular, Inc. | 2009-10-01 |
| MMT-7002 & MMT-7003 GLUCOSE SENSORS ( AUTOMATED BICARBONATE BUFFER TEST SYSTEM) (P980022/S059) | Medtronic Minimed | 2009-10-01 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S032) | ABBOTT MEDICAL | 2009-10-01 |
| INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/INSYNC MARQUIS ICDS (P010031/S144) | Medtronic Cardiac Rhythm Disease Management | 2009-10-01 |
| OPTISENSE RIGHT ATRIAL LEAD (P960013/S038) | ABBOTT MEDICAL | 2009-10-01 |
| ENRHYTHM IPG (P980035/S129) | Medtronic, Inc. | 2009-10-01 |