| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S051) | Abbott Vascular, Inc. | 2010-11-08 |
| ON-X PROSTHESTIC HEART VALVE (P000037/S021) | On-X Life Technologies, Inc. | 2010-11-08 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S032) | Abbott Vascular | 2010-11-08 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S045) | Thoratec Laboratories Corp. | 2010-11-05 |
| SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S006) | Siemens Medical Solution | 2010-11-05 |
| GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S037) | GE Healthcare | 2010-11-05 |
| MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM (P070007/S023) | Medtronic Vascular | 2010-11-05 |
| ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES (P040021/S012) | ABBOTT MEDICAL | 2010-11-05 |
| MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S023) | Medtronic Vascular | 2010-11-05 |
| MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT SYSTEM (P990020/S042) | Medtronic Vascular | 2010-11-05 |
| MAXUM SYSTEM (P010023/S006) | Ototronix, LLC | 2010-11-05 |
| VNS THERAPY SYSTEM PULSE GENERATOR CLEANING PROCESS CHANGE (P970003/S110) | LivaNova USA, Inc. | 2010-11-05 |
| ELEVESS (P050033/S006) | Anika Therapeutics, Inc. | 2010-11-05 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY (P020052/S007) | St Jude Medical | 2010-11-05 |
| IMPLANTABLE INTRATHECAL CATHETERS (P860004/S142) | Medtronic, Inc. | 2010-11-03 |
| KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY (P080018) | Carestream Health, Inc. | 2010-11-03 |
| ZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS (P060037/S009) | Zimmer, Inc. | 2010-11-03 |
| INTERSTIM THERAPY/INTERSTIM II (P970004/S095) | Medtronic Neuromodulation | 2010-11-02 |
| SPINAL CORD STIMULATION SYSTEMS (P840001/S158) | Medtronic Neuromodulation | 2010-11-01 |
| ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S089) | Medtronic, Inc. | 2010-11-01 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S058) | Abbott Vascular, Inc. | 2010-11-01 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S047) | Medtronic, Ireland | 2010-11-01 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM: CARELINK PRO, MMT-7335 VERSION 3.0B (P980022/S086) | Medtronic Minimed | 2010-11-01 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S035) | Abbott Vascular | 2010-11-01 |
| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S026) | Abbott Vascular | 2010-11-01 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S045) | Medtronic, Ireland | 2010-10-29 |
| ADAPTA, RELIA, SENSIA & VERSA (P980035/S182) | Medtronic, Inc. | 2010-10-29 |
| CAPSURE (P850089/S070) | Medtronic Cardiac Rhythm Disease Management | 2010-10-29 |
| ON-X PROSTHETIC HEART VALVE (P000037/S020) | On-X Life Technologies, Inc. | 2010-10-29 |
| SECURA, VIRTUOSO II & MAXIMO II (P980016/S255) | Medtronic Cardiac Rhythm Disease Management | 2010-10-29 |
| FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CRYOCONSOLE SYSTEM (P020045/S029) | Medtronic Cryocath, LP | 2010-10-29 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S031) | Abbott Vascular, Inc. | 2010-10-29 |
| ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA EPIC/EPIC SUPRA VALVES (P040021/S013) | ABBOTT MEDICAL | 2010-10-29 |
| CADENCE FAMILY OF ICDS (P910023/S251) | ABBOTT MEDICAL | 2010-10-29 |
| EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S172) | ABBOTT MEDICAL | 2010-10-29 |
| CONCERTO II, CONSULTA & MAXIMO II (P010031/S211) | Medtronic Cardiac Rhythm Disease Management | 2010-10-29 |
| CAPSURE (P930039/S045) | Medtronic, Inc. | 2010-10-29 |
| CAPSURE & VITATRON CHRYSTALINE (P830061/S057) | Medtronic Cardiac Rhythm Disease Management | 2010-10-29 |
| COOL POINT TUBING SET (P060019/S014) | Irvine Biomedical, Inc. | 2010-10-29 |
| CAPSURE IMPLANTABLE PULSE GENERATOR (P890003/S203) | Medtronic, Inc. | 2010-10-29 |
| SPRINT QUATTRO (P920015/S067) | Medtronic, Inc. | 2010-10-29 |
| IMPLANTABLE MINIATURE TELESCOPE (P050034/S003) | Samsara Vision, Inc. | 2010-10-29 |
| DRIVER/MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS (P030009/S046) | Medtronic, Ireland | 2010-10-27 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S070) | Edwards Lifesciences, LLC | 2010-10-27 |
| SURGICEL ABSORBABLE HEMOSTAT (N12159/S026) | ETHICON, Inc. | 2010-10-27 |
| MULTI-LINK 8TM/MULTI-LINK 8TM LL/MULTI-LINK 8TM SV CORONARY STENT (P020047/S025) | Abbott Vascular | 2010-10-27 |
| ANEURX STENT GRAFT SYSTEM (P990020/S041) | Medtronic Vascular | 2010-10-27 |
| THORATEC HEARTMATE II LVAS (P060040/S012) | ABBOTT MEDICAL | 2010-10-27 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S022) | Medtronic Vascular | 2010-10-27 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S110) | Medtronic, Ireland | 2010-10-27 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S022) | Medtronic Vascular | 2010-10-27 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S019) | Bard Peripheral Vascular, Inc. | 2010-10-27 |
| CERVISTA HPV HR (P080014/S004) | Hologic, Inc. | 2010-10-26 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S021) | Medtronic Vascular | 2010-10-26 |
| DEFLUX INJECTABLE GEL (P000029/S067) | Palette Life Sciences | 2010-10-26 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S008) | Syncardia Systems, LLC | 2010-10-26 |
| SEPRAFILM (P950034/S035) | Baxter Healthcare Corporation | 2010-10-26 |
| APLIGRAF (P950032/S060) | Organogenesis, Inc. | 2010-10-26 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S010) | Ferring Pharmaceuticals, Inc. | 2010-10-25 |
| MYNX CADENCE VASCULAR CLOSURE DEVICE (P040044/S033) | Cordis US Corporation | 2010-10-22 |
| AXSYM AFP (LN 7A48) (P820060/S025) | Abbott Laboratories | 2010-10-20 |
| NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE (P060037/S013) | Zimmer, Inc. | 2010-10-20 |
| HERCEPTEST (P980018/S010) | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-10-20 |
| AXSYM FREE PSA (LN 3C20) (P980007/S012) | Abbott Laboratories | 2010-10-20 |
| FLEXTEND EXTENDABLE/RETRACTABLE ENDOCARDIAL PACING LEADS (P960006/S027) | Boston Scientific | 2010-10-20 |
| AXSYM TOTAL PSA (LN 3C19) (P910007/S020) | Abbott Laboratories | 2010-10-20 |
| HER2 FISH PHARMDX KIT (P040005/S005) | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-10-20 |
| AXSYM CORE 2.0 (P060012/S003) | Abbott Laboratories, Inc. | 2010-10-20 |
| GELFOAM ABSORBABLE GELATIN SPONGE (N18286/S020) | Pfizer, Inc. | 2010-10-19 |
| ENTRUST ICD FAMILY (P980035/S166) | Medtronic, Inc. | 2010-10-19 |
| SUPARTZ (P980044/S012) | Seikagaku Corp. | 2010-10-19 |
| AXSYM HBSAG/CONFIRMATORY (LN 9B01) (P050049/S004) | Abbott Laboratories, Inc. | 2010-10-19 |
| AXSYM ANTI-HCV (LN 5C36) (P970027/S010) | Abbott Laboratories | 2010-10-19 |
| AXSYM AUSAB (LN 3C74) (P060003/S006) | Abbott Laboratories, Inc. | 2010-10-19 |
| ENRYTHM IPG (P980016/S237) | Medtronic Cardiac Rhythm Disease Management | 2010-10-19 |
| ICDS (P910023/S250) | ABBOTT MEDICAL | 2010-10-19 |
| ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S051) | Medtronic, Inc. | 2010-10-19 |
| CARELINK DDMA SOFTWARE AND CARELINK MONITOR (P890003/S191) | Medtronic, Inc. | 2010-10-19 |
| AXSYM CORE-M 2.0 (LN 8B89) (P060009/S002) | Abbott Laboratories, Inc. | 2010-10-19 |
| AXSYM CORE 2.0 (LN 8B88) (P060012/S004) | Abbott Laboratories, Inc. | 2010-10-19 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S106) | Medtronic, Ireland | 2010-10-19 |
| DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S042) | Medtronic, Ireland | 2010-10-19 |
| CRT-DS (P030054/S171) | ABBOTT MEDICAL | 2010-10-19 |
| EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL (P100016) | Carl Zeiss Meditec Production, LLC | 2010-10-19 |
| ADVIA ANTI-HBS ASSAY (P030029/S011) | Siemens Healthcare Diagnostics | 2010-10-18 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S014) | Bard Peripheral Vascular, Inc. | 2010-10-18 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD (P980016/S260) | Medtronic Cardiac Rhythm Disease Management | 2010-10-15 |
| CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO (P010031/S216) | Medtronic Cardiac Rhythm Disease Management | 2010-10-15 |
| TELIGEN PULSE GENERATORS (P960040/S224) | Boston Scientific | 2010-10-15 |
| MARQUIS/MAXIMO/INTRINSIC ICDS (P980016/S259) | Medtronic Cardiac Rhythm Disease Management | 2010-10-15 |
| INSYNC III/II MARQUIS/INSYNC SENTRY/MAXIMO ICDS (P010031/S215) | Medtronic Cardiac Rhythm Disease Management | 2010-10-15 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025/S007) | Medtronic, Inc. | 2010-10-15 |
| ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S188) | Medtronic, Inc. | 2010-10-15 |
| ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S017) | Ahp Eos Buyer, Inc. | 2010-10-15 |
| COGNIS PULSE GENERATORS (P010012/S244) | Boston Scientific Corp | 2010-10-15 |
| SPECTRANETICS ELCA LASER CATHETERS (P910001/S037) | Spectranetics Corp. | 2010-10-15 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S033) | Abbott Vascular | 2010-10-15 |
| MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S057) | Abbott Vascular, Inc. | 2010-10-15 |
| CORONARY DILATATION CATHETERS (P810046/S240) | Advanced Cardiovascular Systems, Inc. | 2010-10-15 |
| MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S024) | Abbott Vascular | 2010-10-15 |