| XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S023) | Abbott Vascular, Inc. | 2009-08-26 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S008) | Allergan | 2009-08-26 |
| REALIZE ADJUSTABLE GASTRIC BAND-C (P070009/S005) | Obtech Medical GmbH | 2009-08-25 |
| SUTURE MEDIATED CLOSURE SYSTEMS, PERCUTANEOUS VASCULAR SURGICAL SYSTEMS/ASSOCIATED ACCESSORIES (P960043/S066) | Abbott Vascular, Inc. | 2009-08-24 |
| STARCLOSE/STARCLOSE SE VASCULAR CLOSURE SYSTEMS (P050007/S018) | Abbott Vascular Devices | 2009-08-24 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S006) | Mentor Corp. | 2009-08-24 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S049) | Cochlear Americas | 2009-08-24 |
| PARADIGM REAL-TIME PUMP & GUARDIAN REAL-TIME MONITOR (P980022/S058) | Medtronic Minimed | 2009-08-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S047) | W. L. Gore & Associates, Inc. | 2009-08-21 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D (P010031/S160) | Medtronic Cardiac Rhythm Disease Management | 2009-08-21 |
| FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S018) | Abbott Laboratories | 2009-08-21 |
| STRAUMANN EMDOGAIN (P930021/S012) | The Straumann Company | 2009-08-21 |
| VIRTUOSO II DR/VR, SECURA DR.VR, MAXIMO II DR/VR (P980016/S199) | Medtronic Cardiac Rhythm Disease Management | 2009-08-21 |
| ADVIA CENTAUR ANTI-HBC IGM (P030040/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV (P030056/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S110) | Medtronic, Inc. | 2009-08-20 |
| ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS (P040020/S014) | Alcon Research, Ltd. | 2009-08-20 |
| ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY (P030049/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HBCT (P040004/S005) | Siemens Healthcare Diagnostics | 2009-08-20 |
| ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS (P030029/S006) | Siemens Healthcare Diagnostics | 2009-08-20 |
| SYNVISC (P940015/S015) | Sanofi Genzyme Corp. | 2009-08-20 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV (P030056/S006) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBCT (P040004/S006) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS (P030029/S007) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 HBSAG & HBSAG CONFIRMATORY (P030049/S007) | Siemens Healthcare Diagnostics | 2009-08-19 |
| ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBC IGM (P030040/S006) | Siemens Healthcare Diagnostics | 2009-08-19 |
| CONFIENT SW AND LIVIAN SW (P960040/S175) | Boston Scientific | 2009-08-18 |
| PRECISION SPINAL CORD STIMULATOR SYSTEM (SCS) (P030017/S094) | Boston Scientific Corp | 2009-08-18 |
| LIVIAN SW (P010012/S191) | Boston Scientific Corp | 2009-08-18 |
| CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS (P860008/S019) | Cardio Command | 2009-08-18 |
| SCULPTRA (P030050/S004) | Q-Med AB | 2009-08-17 |
| LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000) (P010030/S011) | Zoll Manufacturing Corporation | 2009-08-17 |
| ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S037) | Medtronic, Inc. | 2009-08-14 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S006) | Corcym Canada Corp | 2009-08-14 |
| RESTYLANE AND PERLANE INJECTABLE GEL (P040024/S043) | Q-Med AB | 2009-08-14 |
| MMT-7002 & MMT-7003 GLUCOSE SENSORS (P980022/S057) | Medtronic Minimed | 2009-08-13 |
| ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER (P010020/S014) | Boston Scientific Corp | 2009-08-13 |
| FIRESTAR RX PTCA BALLOON DILATATION CATHETER AND DURASTAR RX PTCA BALLOON DILATATION CATHETER (P880003/S098) | Cordis Corp. | 2009-08-13 |
| ADVIA CENTAUR HCV ON CENTAUR CP (P030056/S002) | Siemens Healthcare Diagnostics | 2009-08-13 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S026) | Boston Scientific Corp | 2009-08-13 |
| VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S040) | Alcon Laboratories | 2009-08-13 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S028) | Alcon Research, Ltd. | 2009-08-13 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S017) | Abbott Vascular Devices | 2009-08-13 |
| GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S014) | Lynch Biologics, LLC | 2009-08-12 |
| NAVISTAR THERMOCOOL CATHETER (P030031/S014) | Biosense Webster, Inc. | 2009-08-12 |
| DIGENE HYBRID CAPTURE2 (P890064/S020) | Qiagen Gaithersburg, Inc. | 2009-08-12 |
| FULL FIELD DIGITAL MAMMOGRAPHY (P050014/S002) | Fujifilm Medical System U.S.A., Inc. | 2009-08-11 |
| NAVISTAR RMT CATHETERS (P990025/S017) | Biosense Webster, Inc. | 2009-08-10 |
| CELSIUS RMT AND NAVISTAR RMT CATHETERS (P950005/S025) | Biosense Webster, Inc. | 2009-08-10 |
| ISPHERIC MODEL YA-60BB INTRAOCULAR LENS (P080004/S001) | Hoya Surgical Optics, Inc. | 2009-08-07 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S017) | Cordis US Corporation | 2009-08-07 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S005) | Corcym Canada Corp | 2009-08-07 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S013) | W. L. Gore & Associates, Inc. | 2009-08-07 |
| VISTAKON (SENOFILCON A) CONTACT LENSES (P040045/S006) | Vistakon, Division of Johnson & Johnson Vision Car | 2009-08-07 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S032) | Boston Scientific Corp | 2009-08-07 |
| MEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP) (P860004/S109) | Medtronic, Inc. | 2009-08-06 |
| MEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP) (P990034/S013) | Medtronic, Inc. | 2009-08-06 |
| VISTAKON (SENOFILCON A) CONTACT LENSES (P040045/S008) | Vistakon, Division of Johnson & Johnson Vision Car | 2009-08-06 |
| RESTYLANE AND PERLANE INJECTABLE GEL (P040024/S042) | Q-Med AB | 2009-08-06 |
| INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P (P010015/S063) | Medtronic, Inc. | 2009-08-05 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA ICD FAMILIES (P980016/S181) | Medtronic Cardiac Rhythm Disease Management | 2009-08-05 |
| PRODIGY IPG (P890003/S165) | Medtronic, Inc. | 2009-08-05 |
| KAPPA 400 DR/SR IPG (P970012/S052) | Medtronic, Inc. | 2009-08-05 |
| INSYNC FAMILIES OF ICDS/CONCERTO/MAXIMO II/CONSULTA FAMILIES OF CRT-DS (P010031/S145) | Medtronic Cardiac Rhythm Disease Management | 2009-08-05 |
| DEMA FAMILIES/C & T SERIES DEVICES (P990001/S051) | Medtronic, Inc. | 2009-08-05 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S025) | Boston Scientific Corp | 2009-08-05 |
| KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG (P980035/S130) | Medtronic, Inc. | 2009-08-05 |
| RX ACCULINK/ACCULINK CAROTID STENT SYSTEM (P040012/S030) | Abbott Vascular | 2009-08-05 |
| MYNX VASCULAR CLOSURE DEVICE (P040044/S016) | Cordis US Corporation | 2009-08-04 |
| POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES (P880090/S026) | Bausch & Lomb, Inc. | 2009-07-31 |
| ADVIA CENTAUR AHBS (P030029/S003) | Siemens Healthcare Diagnostics | 2009-07-31 |
| POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES (P840039/S058) | Bausch & Lomb, Inc. | 2009-07-31 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S024) | Hologic, Inc. | 2009-07-31 |
| GENESIS, GENESISXP/DUAL XP, GENESISRC, GENESIS DUAL 4-CHANNEL, EON, EONC, AND EONMINI NEUROSTIMULATION (IPG) SYSTEMS (P010032/S031) | ABBOTT MEDICAL | 2009-07-31 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S004) | Roche Molecular Systems, Inc. | 2009-07-30 |
| CONFIENT/VITALITY (P960040/S177) | Boston Scientific | 2009-07-30 |
| AMPLICOR HCV TEST (P000010/S014) | Roche Molecular Systems, Inc. | 2009-07-30 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S005) | Roche Molecular Systems, Inc. | 2009-07-30 |
| COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP (P000012/S021) | Roche Molecular Systems, Inc. | 2009-07-30 |
| INSYNC II/III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT-DS (P010031/S159) | Medtronic Cardiac Rhythm Disease Management | 2009-07-30 |
| ENRHYTHM IPG (P980035/S139) | Medtronic, Inc. | 2009-07-30 |
| LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS (P070014/S001) | Bard Peripheral Vascular, Inc. | 2009-07-30 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S016) | W. L. Gore & Associates, Inc. | 2009-07-30 |
| CONTAK RENEWAL FAMILY OF CRT-D (P010012/S183) | Boston Scientific Corp | 2009-07-30 |
| RENEWAL/LIVIAN (P010012/S192) | Boston Scientific Corp | 2009-07-30 |
| MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II ICDS (P980016/S198) | Medtronic Cardiac Rhythm Disease Management | 2009-07-30 |
| CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM (P910001/S032) | Spectranetics Corp. | 2009-07-29 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S030) | W. L. Gore & Associates, Inc. | 2009-07-29 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S046) | W. L. Gore & Associates, Inc. | 2009-07-29 |
| LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S010) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P850051/S071) | Medtronic, Inc. | 2009-07-28 |
| LEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT (P900061/S084) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P010015/S070) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P010031/S158) | Medtronic Cardiac Rhythm Disease Management | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P970012/S056) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P980035/S138) | Medtronic, Inc. | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P990001/S055) | Medtronic, Inc. | 2009-07-28 |
| SPECTRANETICS LASER SHEATH (SLS) CATHETERS (P960042/S014) | Spectranetics (Philips) | 2009-07-28 |
| MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P980050/S042) | Medtronic, Inc. | 2009-07-28 |
| CAPSURE VDD LEAD (P890003/S172) | Medtronic, Inc. | 2009-07-28 |