| FREQUENCY 55/58 UV/XCEL/EXPRESSIONS COLORS/ACCENTS/HYDRASOFT (METHAFILCON A & METHAFILCON B) SOFT (HYDROPHILIC) CONTACT (P850079/S051) | CooperVision, Inc. | 2011-11-29 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S075) | Cochlear Americas | 2011-11-29 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S047) | Corcym S.r.l. | 2011-11-29 |
| BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES (P890023/S018) | The Cooper Companies | 2011-11-29 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P030054/S173) | ABBOTT MEDICAL | 2011-11-29 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S006) | CooperVision, Inc. | 2011-11-29 |
| GORE VIABAHN ENDOPROSTHESIS & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S039) | W. L. Gore & Associates, Inc. | 2011-11-23 |
| INSYNC III (P010015/S143) | Medtronic, Inc. | 2011-11-23 |
| CONSULTA & SYNCRA CRT-PS (P010015/S144) | Medtronic, Inc. | 2011-11-23 |
| REPLY & ESPRIT SR/DR (P950029/S064) | MicroPort CRM USA, Inc. | 2011-11-23 |
| WAVELIGHT EX500 LASER SYSTEM (P020050/S006) | Alcon Laboratories, Inc. | 2011-11-23 |
| DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM (P000021/S020) | Siemens Healthcare Diagnostics | 2011-11-23 |
| T-SPOT TB TEST (P070006/S007) | Oxford Immunotec, Ltd. | 2011-11-23 |
| CADENCE FAMILY OF ICDS (P910023/S277) | ABBOTT MEDICAL | 2011-11-23 |
| ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S024) | Hologic, Inc. | 2011-11-23 |
| LCS TOTAL KNEE SYSTEM (P830055/S106) | Depuy, Inc. | 2011-11-23 |
| 350 SERIES/ENRHYTHM/SIGMA (P980035/S247) | Medtronic, Inc. | 2011-11-23 |
| REVO MRI (P090013/S043) | Medtronic, Inc. | 2011-11-23 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S204) | ABBOTT MEDICAL | 2011-11-23 |
| CADENCE FAMILY OF ICDS (P910023/S278) | ABBOTT MEDICAL | 2011-11-23 |
| VITATRON DA+C & T SERIES (P990001/S098) | Medtronic, Inc. | 2011-11-23 |
| WAVELIGHT EX500 LASER SYSTEM (P030008/S006) | Alcon Laboratories, Inc. | 2011-11-23 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S205) | ABBOTT MEDICAL | 2011-11-23 |
| DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM (P020027/S015) | Siemens Healthcare Diagnostics | 2011-11-23 |
| AMS UROLUME ENDOPROSTHESIS (P920023/S023) | Boston Scientific Corp | 2011-11-23 |
| ADVISA (P980035/S248) | Medtronic, Inc. | 2011-11-23 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM & PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S076) | Abbott Vascular, Inc. | 2011-11-23 |
| MODEL 4195 ATTAIN STARFIX LEAD (P060039/S021) | Medtronic, Inc. | 2011-11-22 |
| MEDTRONIC ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR (P980035/S245) | Medtronic, Inc. | 2011-11-22 |
| APLIGRAF (P950032/S065) | Organogenesis, Inc. | 2011-11-22 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010) | Boston Scientific Corp | 2011-11-22 |
| C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C (P060011/S002) | Rayner Intraocular Lenses , Ltd. | 2011-11-22 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S025) | Bard Peripheral Vascular, Inc. | 2011-11-21 |
| CAPSURE FIX (P090013/S028) | Medtronic, Inc. | 2011-11-18 |
| ATTAIN (P010015/S129) | Medtronic, Inc. | 2011-11-18 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S022) | Medtimo, Inc. | 2011-11-18 |
| RELIANCE 4-SITE IS-4 LEADS (P910073/S099) | Boston Scientific | 2011-11-18 |
| ATTAIN STARFIX (P060039/S026) | Medtronic, Inc. | 2011-11-18 |
| STAN S31 FETAL HEART MONITOR (P020001/S009) | Neoventa Medical AB | 2011-11-18 |
| TRANSVENE CS/SVC (P980050/S062) | Medtronic, Inc. | 2011-11-18 |
| CAPSURE/VITATRON CRYSTALINE/EXCELLENCE PS+ (P830061/S066) | Medtronic Cardiac Rhythm Disease Management | 2011-11-18 |
| SELECTSECURE (P030036/S032) | Medtronic Cardiac Rhythm Disease Management | 2011-11-18 |
| SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD (P920015/S078) | Medtronic, Inc. | 2011-11-18 |
| CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE SS+/VITATRON IMPULSE II (P850089/S078) | Medtronic Cardiac Rhythm Disease Management | 2011-11-18 |
| ATTAIN ABILITY (P080006/S029) | Medtronic, Inc. | 2011-11-18 |
| CAPSURE (P890003/S229) | Medtronic, Inc. | 2011-11-18 |
| SPECTRANETICS LASER SHEATH (SLSII) (P960042/S023) | Spectranetics (Philips) | 2011-11-18 |
| SPECTRANETICS CORONARY ATHERECTOMY (ELCA) CATHETERS (P910001/S040) | Spectranetics Corp. | 2011-11-18 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+ (P930039/S056) | Medtronic, Inc. | 2011-11-18 |
| CONSULTA CRT-D, MAXIMO II CRT-D, & VARIOUS FAMILIES/MODELS OF CONCERTO, INSYNC, & PROTECTA (P010031/S277) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| JEWEL AF, GEM III AT (P980050/S067) | Medtronic, Inc. | 2011-11-17 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170 (P090009/S005) | Roche Diagnostics Corp. | 2011-11-17 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S031) | Boston Scientific | 2011-11-17 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S029) | Bard Peripheral Vascular, Inc. | 2011-11-17 |
| KAPPA 400 IPG (P970012/S089) | Medtronic, Inc. | 2011-11-17 |
| REVO MRI (P090013/S040) | Medtronic, Inc. | 2011-11-17 |
| E-LUMINEXX VASCULAR STENT (P080007/S009) | Bard Peripheral Vascular, Inc. | 2011-11-17 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S005) | Roche Diagnostics Corp. | 2011-11-17 |
| AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S089) | Advanced Bionics | 2011-11-17 |
| CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES (P980003/S031) | Boston Scientific Corp | 2011-11-17 |
| DIVA IPG FAMILY, DEMA IPG FAMILY, & VARIOUS C-SERIES & T-SERIES DEVICES (P990001/S096) | Medtronic, Inc. | 2011-11-17 |
| STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM (P930016/S036) | Amo Manufacturing USA, LLC | 2011-11-17 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S016) | Roche Diagnostics Corp. | 2011-11-17 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S064) | W. L. Gore & Associates, Inc. | 2011-11-17 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010 (P100032/S004) | Roche Diagnostics Corp. | 2011-11-17 |
| BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES (P920047/S049) | Boston Scientific Corp | 2011-11-17 |
| CONSULTA CRT-P, SYNCRA CRT-P, INSYNC/INSYNC III (P010015/S139) | Medtronic, Inc. | 2011-11-17 |
| BARD LIFESTENT SOLO VASCULAR STENT SYSTEMS (P070014/S027) | Bard Peripheral Vascular, Inc. | 2011-11-17 |
| ENTRUST, INTRINSIC, MARQUIS, ONYX, SECURA, & VARIOUS FAMILIES/MODELS OF GEM, MAXIMO, PROTECTA, & VIRTUOSO (P980016/S323) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| VARIOUS FAMILIES/MODELS OF PASYS, SPECTRAX, SYMBIOS, & SYNERGYST (P820003/S113) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, RELIA, SENSIA, SIGMA, VERSA, & VARIOUS FAMILIES/MODELS OF KAPPA (P980035/S242) | Medtronic, Inc. | 2011-11-17 |
| PRODIGY, MINUET, SYNERGYST II, & VARIOUS FAMILIES/MODELS OF ELITE, PREVA, THERA, & VITATRON LEGACY (P890003/S235) | Medtronic, Inc. | 2011-11-17 |
| INCEPTA, ENERGEN, PUNCTUA AND COGNIS CRT-D (P010012/S255) | Boston Scientific Corp | 2011-11-17 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170 (P100031/S004) | Roche Diagnostics Corp. | 2011-11-17 |
| VITATRON LEGACY, PREVAIL, PREMIER, & VARIOUS FAMILIES/MODELS OF ACTIVITRAX, LEGEND, MINIX (P850051/S078) | Medtronic, Inc. | 2011-11-17 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S011) | Roche Diagnostics Corp. | 2011-11-17 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S022) | Bard Peripheral Vascular | 2011-11-17 |
| INCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS (P960040/S235) | Boston Scientific | 2011-11-17 |
| LEGEND PLUS (P930022/S013) | Medtronic, Inc. | 2011-11-17 |
| GEM, PCD, & VARIOUS FAMILIES/MODELS OF JEWEL (P900061/S110) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| LUMAX 500/540 ICDS THORACIC IMPEDANCE (P050023/S047) | Biotronik, Inc. | 2011-11-17 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 (P090008/S005) | Roche Diagnostics Corp. | 2011-11-17 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S010) | Roche Diagnostics Corp. | 2011-11-16 |
| LIFESTAR VASCULAR STENT SYSTEMS (P080007/S007) | Bard Peripheral Vascular, Inc. | 2011-11-16 |
| SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL (P090022/S009) | Lenstec, Inc. | 2011-11-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S004) | Roche Diagnostics Corp. | 2011-11-16 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S027) | Coloplast Corp. | 2011-11-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010 (P100032/S002) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170 (P100031/S002) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E170 (P090009/S004) | Roche Diagnostics Corp. | 2011-11-16 |
| ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 601 (P090008/S004) | Roche Diagnostics Corp. | 2011-11-16 |
| XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S083) | Abbott Vascular, Inc. | 2011-11-15 |
| ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE (P930038/S069) | Terumo Medical Corporation | 2011-11-15 |
| ETI-AB-AUK PLUS KIT (P990042/S010) | DiaSorin, Inc. | 2011-11-15 |
| ETI-AB-COREK PLUS KIT (P990045/S011) | DiaSorin, Inc. | 2011-11-15 |
| ETI-AB-EBK PLUS KIT (P990041/S013) | DiaSorin, Inc. | 2011-11-15 |
| ETI-MAK-2 PLUS KIT (P990038/S014) | DiaSorin, Inc. | 2011-11-15 |
| ETI-CORE-IGMK PLUS KIT (P990044/S011) | DiaSorin, Inc. | 2011-11-15 |
| MEDTRONIC OPEN PIVOT HEART VALVE (P990046/S025) | Medtronic Ats Medical, Inc. | 2011-11-15 |
| NMP22 BLADDERCHEK TEST KIT (P940035/S006) | Abbott Diagnostics Scarborough, Inc. | 2011-11-15 |