| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S154) | ABBOTT MEDICAL | 2010-07-15 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S087) | Medtronic, Inc. | 2010-07-15 |
| SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS (P980016/S241) | Medtronic Cardiac Rhythm Disease Management | 2010-07-15 |
| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S193) | Medtronic, Inc. | 2010-07-15 |
| JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD (P980050/S049) | Medtronic, Inc. | 2010-07-15 |
| MINILINK TRANSMITTER (MMT-7703) & IPRO DIGITAL RECORDER (MMT-7709) (P980022/S078) | Medtronic Minimed | 2010-07-15 |
| CELSIUS THERMOCOOL CATHETER (P030031/S030) | Biosense Webster, Inc. | 2010-07-15 |
| FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S071) | ABBOTT MEDICAL | 2010-07-15 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S021) | Coloplast Corp. | 2010-07-14 |
| INTERSTIM II MODEL 3058 DEVICE (P970004/S088) | Medtronic Neuromodulation | 2010-07-14 |
| ATS 3F AORTIC BIOPROSTHESIS MODEL 1000 (P060025/S005) | Medtronic, Inc. | 2010-07-13 |
| MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709) (P980022/S077) | Medtronic Minimed | 2010-07-12 |
| EPIC HF CRT-D SYSTEM (P030054/S149) | ABBOTT MEDICAL | 2010-07-09 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S025) | Cordis US Corporation | 2010-07-09 |
| T-SPOT TB TEST (P070006/S001) | Oxford Immunotec, Ltd. | 2010-07-09 |
| CADENCE ICD SYSTEM (P910023/S233) | ABBOTT MEDICAL | 2010-07-09 |
| PARADYM CRT (P060027/S025) | MicroPort CRM USA, Inc. | 2010-07-09 |
| PARADYM DR/VR (P980049/S058) | MicroPort CRM USA, Inc. | 2010-07-09 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S069) | Edwards Lifesciences, LLC | 2010-07-09 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S024) | Abbott Laboratories | 2010-07-09 |
| ATTAIN ABILITY (P080006/S009) | Medtronic, Inc. | 2010-07-08 |
| FALOPE-RING BAND & APPLICATOR SYSTEMS (P870076/S011) | Gyrus Acmi, Inc. | 2010-07-08 |
| MEDTRONIC VASULAR TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S020) | Medtronic Vascular | 2010-07-08 |
| ATTAIN STARFIX (P060039/S012) | Medtronic, Inc. | 2010-07-08 |
| TECNIS ONE-PIECE SOFT ACRYLIC INTRAOCULAR (IOL) MODEL ZCB00 & TECNIS MULTIFOCAL ONE-PIECE IOL MODEL ZMB00 (P980040/S034) | Johnson & Johnson Surgical Vision, Inc. | 2010-07-08 |
| ENTRUST (P980016/S246) | Medtronic Cardiac Rhythm Disease Management | 2010-07-08 |
| ENRHYTHM IPG (P980035/S172) | Medtronic, Inc. | 2010-07-08 |
| TAXUS LIBERTE & TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S056) | Boston Scientific Corp | 2010-07-08 |
| SELECTSECURE (P030036/S017) | Medtronic Cardiac Rhythm Disease Management | 2010-07-08 |
| ATTAIN OTW & ATTAIN BIPOLAR OTW (P010015/S090) | Medtronic, Inc. | 2010-07-08 |
| CVX-300 LASER SYSTEM (P910001/S033) | Spectranetics Corp. | 2010-07-08 |
| VERIFLEX (LIBERTE) STENT DELIVERY SYSTEM (P040016/S060) | Boston Scientific Scimed, Inc. | 2010-07-08 |
| GENESYS HTA SYSTEM (P000040/S016) | Axora Medical, Inc. | 2010-07-08 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S014) | Stryker Corp. | 2010-07-08 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S007) | Corcym Canada Corp | 2010-07-08 |
| MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM (P070007/S020) | Medtronic Vascular | 2010-07-08 |
| EZ STEER THERMOCOOL NAV CATHETER (P030031/S022) | Biosense Webster, Inc. | 2010-07-07 |
| EZ STEER THERMOCOOL NAV CATHETER (P040036/S015) | Biosense Webster, Inc. | 2010-07-07 |
| ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS (P980016/S245) | Medtronic Cardiac Rhythm Disease Management | 2010-07-07 |
| CONCERTO/CONSULTA CRT-DS/CONCERTO II ICD/MAXIMO II CRT-D (P010031/S202) | Medtronic Cardiac Rhythm Disease Management | 2010-07-07 |
| CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S005) | Ceramtec GmbH | 2010-07-06 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S017) | Coloplast Corp. | 2010-07-02 |
| FREQUENCY SPHERE & ASPHERE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P850079/S048) | CooperVision, Inc. | 2010-07-02 |
| PRODISC-C TOTAL DISC REPLACEMENT (P070001/S008) | Centinel Spine, LLC | 2010-07-02 |
| PRODISC-C TOTAL DISC REPLACEMENT (P070001/S007) | Centinel Spine, LLC | 2010-07-02 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S016) | Zoll Manufacturing Corporation | 2010-07-02 |
| MACROPLASTIQUE IMPLANTS (P040050/S005) | Uroplasty, LLC | 2010-07-02 |
| DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S043) | Medtronic, Ireland | 2010-07-01 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S019) | Medtronic Vascular | 2010-07-01 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S019) | Medtronic Vascular | 2010-07-01 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S056) | Medtronic, Inc. | 2010-07-01 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S053) | Medtronic, Inc. | 2010-07-01 |
| COSEAL SURGICAL SEALANT (P030039/S016) | Baxter Bio Science | 2010-07-01 |
| IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034) | Samsara Vision, Inc. | 2010-07-01 |
| GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S108) | Medtronic, Ireland | 2010-07-01 |
| ANEURX STENT GRAFT SYSTEM (P990020/S040) | Medtronic Vascular | 2010-07-01 |
| ADAPTA/SENSIA/VERSA/RELIA/ENRHYTHM IPGS (P980035/S171) | Medtronic, Inc. | 2010-06-30 |
| PREPSTAIN SYSTEM (P970018/S021) | Bd Diagnostic Systems | 2010-06-30 |
| INSYNC III CRT-P (P010015/S089) | Medtronic, Inc. | 2010-06-30 |
| SYNCHROMED INFUSION SYSTEM (P860004/S132) | Medtronic, Inc. | 2010-06-30 |
| MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD (P060039/S010) | Medtronic, Inc. | 2010-06-30 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S071) | ABBOTT MEDICAL | 2010-06-30 |
| BLAZER PRIME HTD CATHETER (P920047/S042) | Boston Scientific Corp | 2010-06-30 |
| SPINAL CORD STIMULATION SYSTEMS (P840001/S154) | Medtronic Neuromodulation | 2010-06-30 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S055) | Medtronic, Inc. | 2010-06-30 |
| INSYNC ICD MODEL 7272 (P010031/S201) | Medtronic Cardiac Rhythm Disease Management | 2010-06-30 |
| INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S086) | Medtronic Neuromodulation | 2010-06-30 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS (P980016/S244) | Medtronic Cardiac Rhythm Disease Management | 2010-06-30 |
| BLAZER PRIME XP CATHETER (P020025/S023) | Boston Scientific | 2010-06-30 |
| ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S084) | Medtronic, Inc. | 2010-06-30 |
| HER2 FISH PHARMDX KIT (P040005/S004) | Agilent Technologies Singapore (International) Pte , Ltd. | 2010-06-29 |
| DEV-0016 CARELINK PERSONAL SOFTWARE VERSION 1.0A (P980022/S073) | Medtronic Minimed | 2010-06-29 |
| SOFT ACRYLIC INTRAOCULAR LENS (P960028/S032) | Johnson & Johnson Surgical Vision, Inc. | 2010-06-29 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S001) | Integra LifeSciences Corporation | 2010-06-29 |
| AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES/TECNIS 1-PIECE LENS MODEL ZCB00 (P980040/S030) | Johnson & Johnson Surgical Vision, Inc. | 2010-06-29 |
| AMO TECNIS LENS MODEL ZA9003 (P990080/S033) | Johnson & Johnson Surgical Vision, Inc. | 2010-06-29 |
| OVATIO CRT-D AND PARADYM CRT-D (P060027/S024) | MicroPort CRM USA, Inc. | 2010-06-28 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S010) | Natus Medical Incorporated | 2010-06-28 |
| MEDTRONIC ACTIVA RC AND PC NEUROSTIMULATORS (P960009/S083) | Medtronic, Inc. | 2010-06-28 |
| NAVISTAR RMT THERMOCOOL CATHETER (P030031/S024) | Biosense Webster, Inc. | 2010-06-28 |
| CERVISTA HPV HR (P080014/S002) | Hologic, Inc. | 2010-06-28 |
| CADENCE ICDS (P910023/S229) | ABBOTT MEDICAL | 2010-06-28 |
| OVATIO VR/DR AND PARADYM VR/DR ICDS (P980049/S057) | MicroPort CRM USA, Inc. | 2010-06-28 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S013) | Boston Scientific Corp | 2010-06-28 |
| CELSIUS RMT THERMOCOOL CATHETER (P040036/S017) | Biosense Webster, Inc. | 2010-06-28 |
| REPLY / ESPRIT PACEMAKERS (P950029/S053) | MicroPort CRM USA, Inc. | 2010-06-28 |
| CERVISTA HPV 16/18 (P080015/S001) | Hologic, Inc. | 2010-06-28 |
| EPIC HF CRT-DS (P030054/S144) | ABBOTT MEDICAL | 2010-06-28 |
| PRO-DISC C TOTAL DISC REPLACEMENT (P070001/S006) | Centinel Spine, LLC | 2010-06-25 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027) | OraSure Technologies, Inc. | 2010-06-25 |
| RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER (P020052/S006) | St Jude Medical | 2010-06-25 |
| DA+ C-SERIES AND DA+ T-SERIES (P990001/S070) | Medtronic, Inc. | 2010-06-25 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S170) | Medtronic, Inc. | 2010-06-25 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S088) | Medtronic, Inc. | 2010-06-25 |
| LIVEWIRE TC AND SAFIRE ABLATION CATHETERS (P960016/S029) | St Jude Medical | 2010-06-25 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S079) | Cordis Corp. | 2010-06-24 |
| SYNCHROMED INFUSION SYSTEM (P860004/S131) | Medtronic, Inc. | 2010-06-24 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX (P860057/S068) | Edwards Lifesciences, LLC | 2010-06-24 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S106) | Boston Scientific Corp | 2010-06-23 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S026) | W. L. Gore & Associates, Inc. | 2010-06-23 |