| PARADYM ICDS AND CRT-D DEVICES (P980049/S060) | MicroPort CRM USA, Inc. | 2010-09-08 |
| COGNIS (P010012/S237) | Boston Scientific Corp | 2010-09-07 |
| ETHICON OMNEX SURGICAL SEALANT APPLICATOR AND PACKAGING (P060029/S001) | ETHICON, Inc. | 2010-09-07 |
| TELIGEN (P960040/S218) | Boston Scientific | 2010-09-07 |
| HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM (P010025/S020) | Hologic, Inc. | 2010-09-07 |
| DEFLUX INJECTABLE GEL (P000029/S066) | Palette Life Sciences | 2010-09-03 |
| IMPLANTABLE PULSE GENERATOR, PACEMAKER (P010012/S248) | Boston Scientific Corp | 2010-09-03 |
| H120 & H125 CONTAK RENEWAL TR IS-1 (P030005/S068) | Guidant Corp. | 2010-09-03 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK (P000025/S047) | Med-El Corp. | 2010-09-03 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S030) | Baxter Healthcare Corp | 2010-09-03 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S046) | Med-El Corp. | 2010-09-03 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S228) | Boston Scientific | 2010-09-03 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S107) | Boston Scientific Corp | 2010-09-03 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078) | Cordis Corp. | 2010-09-02 |
| DIMENSIONS TPSA FLE REAGENT CARTRIDGE (P000021/S017) | Siemens Healthcare Diagnostics | 2010-09-02 |
| IMPLANTABLE PULSE GENERATOR, PACEMAKER (P010012/S249) | Boston Scientific Corp | 2010-09-02 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S032) | CooperSurgical, Inc. | 2010-09-02 |
| PRECISE OTW/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S022) | Cordis US Corporation | 2010-09-02 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S229) | Boston Scientific | 2010-09-02 |
| LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S018) | Alcon Laboratories, Inc. | 2010-09-02 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S044) | Abbott Vascular, Inc. | 2010-09-02 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S016) | DePuy Orthopaedics, Inc. | 2010-09-02 |
| SMART NITINOL STENT & SMART CONTROL NITINOL STENT SYSTEMS (P020036/S019) | Cordis US Corporation | 2010-09-02 |
| RELIATY/MODEL 3145 PACING SYSTEM ANALYZER (P950037/S079) | Biotronik, Inc. | 2010-09-02 |
| DIMENSIONS FPSA FLEX REAGENT CARTRIDGE (P020027/S012) | Siemens Healthcare Diagnostics | 2010-09-02 |
| SPECTRANETICS LASER SHEATH II PRODUCTS (P960042/S019) | Spectranetics (Philips) | 2010-09-01 |
| VERIFLEX (LIBERTE) STENT DELIVERY SYSTEM (P040016/S062) | Boston Scientific Scimed, Inc. | 2010-09-01 |
| ENDEAVOR ZOTAROLIMUS-ELUTING STENT SYSTEM (P060033/S057) | Medtronic, Inc. | 2010-09-01 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S022) | W. L. Gore & Associates, Inc. | 2010-09-01 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S058) | Boston Scientific Corp | 2010-09-01 |
| EXPRESS SD PREMOUNTED STENT SYSTEM (P060006/S015) | Boston Scientific Corp | 2010-09-01 |
| PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX) (P860019/S260) | Scimed Life Systems, Inc. | 2010-09-01 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP MODEL 8637 (P860004/S137) | Medtronic, Inc. | 2010-09-01 |
| COBAS TAQMAN HCV TEST VERSION 2.0 (P060030/S006) | Roche Molecular Systems, Inc. | 2010-09-01 |
| ADVIA CENTAUR ANTI-HBS (AHBS) (P030029/S009) | Siemens Healthcare Diagnostics | 2010-09-01 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S022) | Zoll Manufacturing Corporation | 2010-09-01 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S021) | W. L. Gore & Associates, Inc. | 2010-09-01 |
| MULTI-LINK 8 SMALL VESSEL CORONARY STENT SYSTEM (P020047/S022) | Abbott Vascular | 2010-08-31 |
| ABBOTT ARCHITECT TOTAL PSA ASSAY (P910007/S018) | Abbott Laboratories | 2010-08-31 |
| ARCHITECT FREE PSA ASSAY (P980007/S010) | Abbott Laboratories | 2010-08-31 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S027) | Biomet Manufacturing Corp | 2010-08-31 |
| ADVIA CENTAUR PSA ASSAY (P950021/S012) | Siemens Healthcare Diagnostics | 2010-08-30 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S012) | Roche Molecular Systems, Inc. | 2010-08-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR; HBSAG CONFIRMATORY KIT (P000044/S024) | Ortho-Clinical Diagnostics, Inc. | 2010-08-30 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S008) | Roche Molecular Systems, Inc. | 2010-08-30 |
| ADVIA CENTAUR CPSA ASSAY (P990055/S013) | Siemens Healthcare Diagnostics | 2010-08-30 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S043) | Abbott Vascular, Inc. | 2010-08-27 |
| KAPPA 400 DR/SR IPG (P970012/S074) | Medtronic, Inc. | 2010-08-27 |
| INSYNC CRT-P & INSYNC III CRT-P (P010015/S098) | Medtronic, Inc. | 2010-08-27 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S166) | ABBOTT MEDICAL | 2010-08-27 |
| SMART/SMART CONTROL NITINOL STENT SYSTEMS (P020036/S018) | Cordis US Corporation | 2010-08-27 |
| CAPSURE PACING LEAD (P930039/S043) | Medtronic, Inc. | 2010-08-27 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S184) | Medtronic, Inc. | 2010-08-27 |
| DEMA IPG/C & T SERIES (P990001/S075) | Medtronic, Inc. | 2010-08-27 |
| ADAPTA/VERSA/SENSIA/RELIA (P980035/S185) | Medtronic, Inc. | 2010-08-27 |
| ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S091) | Medtronic, Inc. | 2010-08-27 |
| INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S214) | Medtronic Cardiac Rhythm Disease Management | 2010-08-27 |
| CADENCE FAMILY OF ICDS (P910023/S247) | ABBOTT MEDICAL | 2010-08-27 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S063) | Terumo Medical Corporation | 2010-08-27 |
| PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENTS SYSTEMS (P030047/S021) | Cordis US Corporation | 2010-08-27 |
| UROLOGIX TARGIS SYSTEM (P970008/S052) | Urologix, LLC | 2010-08-27 |
| GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS (P980016/S258) | Medtronic Cardiac Rhythm Disease Management | 2010-08-27 |
| SPINAL CORD STIMULATION SYSTEMS (P840001/S160) | Medtronic Neuromodulation | 2010-08-27 |
| CONCERTO/CONSULTA/MAXIMO II/ CONCERTO II CRT-DS (P010031/S213) | Medtronic Cardiac Rhythm Disease Management | 2010-08-26 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENS (P030016/S014) | STAAR Surgical Company | 2010-08-26 |
| VISTAKON (ETAFILCON A) CONTACT LENS (N18033/S045) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2010-08-26 |
| STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S026) | Starr Surgical Co. | 2010-08-26 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S029) | Boston Scientific Corp | 2010-08-26 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S078) | Boston Scientific Corp | 2010-08-26 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S042) | Abbott Vascular, Inc. | 2010-08-26 |
| BLAZER II/BLAZER PRIME HTD ABLATION CATHETERS (P920047/S043) | Boston Scientific Corp | 2010-08-26 |
| VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S257) | Medtronic Cardiac Rhythm Disease Management | 2010-08-26 |
| STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S028) | Starr Surgical Co. | 2010-08-26 |
| BLAZER II XP/BLAZER PRIME XP ABLATION CATHETERS (P020025/S024) | Boston Scientific | 2010-08-26 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK ADVANCER (P900056/S102) | Boston Scientific Corp | 2010-08-26 |
| STAAR SURGICAL IMPLANTABLE COLLAMER LENS (P030016/S016) | STAAR Surgical Company | 2010-08-26 |
| TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S019) | Shire Regenerative Medicine | 2010-08-25 |
| C & T SERIES IPG (P990001/S074) | Medtronic, Inc. | 2010-08-25 |
| DEXCOM SEVEN & SEVEN PLUS (P050012/S028) | Dexcom, Inc. | 2010-08-25 |
| DEXCOM SEVEN & SEVEN PLUS SYSTEM (P050012/S032) | Dexcom, Inc. | 2010-08-25 |
| HYDRELLE (P050033/S009) | Anika Therapeutics, Inc. | 2010-08-25 |
| ENRHYTHM IPG (P980035/S183) | Medtronic, Inc. | 2010-08-25 |
| DEXCOM SEVEN & SEVEN PLUS SYSTEM (P050012/S029) | Dexcom, Inc. | 2010-08-25 |
| HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S085) | Advanced Bionics | 2010-08-24 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S080) | Medtronic Minimed | 2010-08-23 |
| EXABLATE (P040003/S008) | Insightec, Ltd. | 2010-08-23 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S059) | Cochlear Americas | 2010-08-20 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR, MODELS 203 AND 203A (P850064/S018) | Bunnell, Inc. | 2010-08-20 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS (P980016/S256) | Medtronic Cardiac Rhythm Disease Management | 2010-08-20 |
| LUMAX FAMILIES OF ICDS & CRT-DS (P050023/S036) | Biotronik, Inc. | 2010-08-20 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S084) | Advanced Bionics | 2010-08-20 |
| GENESYS/HTA SYSTEM (P000040/S017) | Axora Medical, Inc. | 2010-08-20 |
| INSYNC SENTRY/III MARQUIS/II MARQUIS/MAXIMO/CONCERTO ICDS/CONSULTA/MAXIMO II/CONCERTO II CRT-DS (P010031/S212) | Medtronic Cardiac Rhythm Disease Management | 2010-08-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S021) | Ortho-Clinical Diagnostics, Inc. | 2010-08-19 |
| VISTAKON (SENOFILCON A) CONTACT LENS (P040045/S012) | Vistakon, Division of Johnson & Johnson Vision Car | 2010-08-19 |
| REPLY DR/SR & REPLY DR/SR (V2)/ESPRIT DR/SR (P950029/S054) | MicroPort CRM USA, Inc. | 2010-08-18 |
| ISPAN PERFLUOROPROPANE C3F8 GAS (P900066/S010) | Airgas Therapeutics, LLC | 2010-08-18 |
| MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (P820003/S098) | Medtronic Cardiac Rhythm Disease Management | 2010-08-18 |
| APLIGRAF (P950032/S045) | Organogenesis, Inc. | 2010-08-17 |
| ESTEEM (P090018/S002) | Envoy Medical Corporation | 2010-08-16 |