| OCUFILCON D SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P890023/S019) | The Cooper Companies | 2013-08-21 |
| COBAS HPV TEST (P100020/S009) | Roche Molecular Systems, Inc. | 2013-08-21 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S003) | Abbott Molecular | 2013-08-20 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETERIAL ABALTION SYSTEM (P010013/S048) | Hologic, Inc. | 2013-08-20 |
| ABBOTT REALTIME HBV (P080026/S009) | Abbott Molecular, Inc. | 2013-08-20 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S034) | Beckman Coulter, Inc. | 2013-08-20 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S007) | Beckman Coulter, Inc. | 2013-08-20 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S024) | Beckman Coulter, Inc. | 2013-08-20 |
| POLYMACON SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P780007/S051) | CooperVision, Inc. | 2013-08-20 |
| MENTOR SPECTRUM BREAST IMPLANTS (P990075/S024) | Mentor Worldwide, LLC | 2013-08-20 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR SYSTEM (S-ICD) (P110042/S012) | Boston Scientific Corporation | 2013-08-20 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S023) | Beckman Coulter, Inc. | 2013-08-20 |
| ABBOTT REALTIME HCV (P100017/S007) | Abbott Molecular, Inc. | 2013-08-20 |
| DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM (P050012/S051) | Dexcom, Inc. | 2013-08-19 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S010) | Dexcom, Inc. | 2013-08-19 |
| DURASPHERE INJECTABLE BULKING AGENT (P980053/S015) | Carbon Medical Technologies, Inc. | 2013-08-19 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S099) | Advanced Bionics | 2013-08-19 |
| HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR (P960058/S102) | Advanced Bionics | 2013-08-19 |
| MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F) (P040044/S047) | Cordis US Corporation | 2013-08-19 |
| REGENT MECHANICAL HEART VALVE (P810002/S084) | ABBOTT MEDICAL | 2013-08-19 |
| AMPLATZER DUCT OCCLUDER II (P020024/S037) | ABBOTT MEDICAL | 2013-08-18 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S175) | Boston Scientific Corp | 2013-08-16 |
| NIT-OCCLUD PDA (P120009) | Pfm Medical, Inc. | 2013-08-16 |
| CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS (P860057/S110) | Edwards Lifesciences, LLC | 2013-08-16 |
| VISTAKON(SENOFILCON A) BRAND CONTACT LENSES,VISTAKON(ETAFILCON A) BRAND CONTACT LENSES (N18033/S073) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2013-08-16 |
| SCULPTRA AND SCULPTRA AESTHETIC (P030050/S018) | Q-Med AB | 2013-08-16 |
| VISTAKON(ETAFILCON A) BRAND CONTACT LENSES,VISTAKON(SENOFILCON A) BRAND CONTACT LENSES (P040045/S040) | Vistakon, Division of Johnson & Johnson Vision Car | 2013-08-16 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S018) | Boston Scientific Corp | 2013-08-15 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S073) | Med-El Corp. | 2013-08-15 |
| SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV AND HEALON5 (P810031/S050) | Johnson & Johnson Surgical Vision, Inc. | 2013-08-15 |
| SCS ACCESSORY KIT (P010032/S071) | ABBOTT MEDICAL | 2013-08-15 |
| SCULPTRA AESTHETIC (P030050/S015) | Q-Med AB | 2013-08-15 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S427) | Medtronic Cardiac Rhythm Disease Management | 2013-08-14 |
| IFORIA VR-T ICD, LLESTO VR-T ICD, LUMAX VR-T ICD,IFORIA VR-T DX ICD, LLESTO VR-T DX ICD, LUMAX VR-T DX ICD, (P050023/S068) | Biotronik, Inc. | 2013-08-14 |
| AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S096) | Boston Scientific Corp | 2013-08-14 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S042) | Boston Scientific | 2013-08-14 |
| ECURO, EFFECTA, ESTELLA,EVIA, ENTOVIS IMPLANTABLE PACEMAKER (P950037/S126) | Biotronik, Inc. | 2013-08-14 |
| PERFLUORON (P950018/S011) | Alcon Laboratories | 2013-08-14 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S005) | Dexcom, Inc. | 2013-08-14 |
| GENESYS HTA SYSTEM (P000040/S029) | Axora Medical, Inc. | 2013-08-14 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S388) | Medtronic Cardiac Rhythm Disease Management | 2013-08-14 |
| ENTOVIS HF(-T) CRT-P, EVIA HF(-T) CRT-P, STRATOS CRT-P (P070008/S045) | Biotronik, Inc. | 2013-08-14 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S002) | Abbott Molecular | 2013-08-13 |
| PARASYM CRT-D 8750 (P060027/S051) | MicroPort CRM USA, Inc. | 2013-08-13 |
| PARADYM VR 8750, PARADYM DR8750 (P980049/S083) | MicroPort CRM USA, Inc. | 2013-08-13 |
| APLIGRAF (P950032/S074) | Organogenesis, Inc. | 2013-08-13 |
| PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT (P100044/S010) | Intersect Ent. | 2013-08-13 |
| AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE (P810025/S034) | Bausch & Lomb, Inc. | 2013-08-13 |
| REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR (P950029/S080) | MicroPort CRM USA, Inc. | 2013-08-13 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S043) | Endologix, LLC | 2013-08-12 |
| SUBCUTANEOUS IMPLANTABLE DEFIB RILLATOR (S-ICD) SYSTEM (P110042/S011) | Boston Scientific Corporation | 2013-08-12 |
| ADAPTA, VERSA, SENSIA, ADVISA DR/DR MRI, RELIA IPG'S (P980035/S339) | Medtronic, Inc. | 2013-08-12 |
| CONSULTA ICD & BRAVA, CONCERTO II, MAXIMO II,PROTECTA/PROTECTA XT, VIVA S/XT CRT- D'S (P010031/S389) | Medtronic Cardiac Rhythm Disease Management | 2013-08-12 |
| ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC (P100031/S009) | Roche Diagnostics Corp. | 2013-08-12 |
| VARIOUS MODELS OF THE ITREL 4, RESTORE, AND SURE SCAN MRI FAMILES OF IMPLANTABLE SPINAL CORD STIMULATORS (P840001/S245) | Medtronic Neuromodulation | 2013-08-12 |
| EVERA S DR/VR & XT DR/ VR, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO II DR/ VR ICD'S (P980016/S428) | Medtronic Cardiac Rhythm Disease Management | 2013-08-12 |
| CONSULTA AND SYNCRA CRT-P'S (P010015/S210) | Medtronic, Inc. | 2013-08-12 |
| ACTIVA PC, SC, AND RC IMPLANTABLE DEEP BRAIN STIMULATORS (P960009/S176) | Medtronic, Inc. | 2013-08-12 |
| REVO MRI IPG (P090013/S108) | Medtronic, Inc. | 2013-08-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S036) | Edwards Lifesciences, LLC | 2013-08-09 |
| MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER (P820003/S122) | Medtronic Cardiac Rhythm Disease Management | 2013-08-09 |
| IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X (P050034/S010) | Samsara Vision, Inc. | 2013-08-09 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S022) | Edwards Lifesciences, LLC | 2013-08-09 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S007) | Dexcom, Inc. | 2013-08-09 |
| REGENT, STANDARD, AND MASTERS MECHANICAL HEART VALVE (P810002/S087) | ABBOTT MEDICAL | 2013-08-08 |
| ABBOTT ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT (P110029/S012) | Abbott Laboratories | 2013-08-08 |
| NOVOTTF-100A SYSTEM (P100034/S004) | Novocure, GmbH | 2013-08-08 |
| THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S071) | Therakos Development Limited | 2013-08-08 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S027) | Neomend, Inc. | 2013-08-08 |
| ARCTIC MODEL FRONT CARDIAC CRYOABLATION SYSTEM (P100010/S029) | Medtronic Cryocath, LP | 2013-08-07 |
| VENTAK (P830060/S075) | Boston Scientific | 2013-08-07 |
| DUOVISC & DISCOVISC OPTHALMIC VISCOSURGICAL DEVICES (P840064/S055) | Alcon Laboratories | 2013-08-07 |
| SWEET TIP RX/ FLEXTEND LEAD FAMILY (P960006/S039) | Boston Scientific | 2013-08-07 |
| FINLINE LEAD FAMILY (P960004/S061) | Boston Scientific | 2013-08-07 |
| OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT (P990046/S035) | Medtronic Ats Medical, Inc. | 2013-08-07 |
| MAESTRO COCHLEAR IMPLANT SYSTEM (P000025/S071) | Med-El Corp. | 2013-08-07 |
| MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) (P110002) | Highridge Medical, LLC | 2013-08-07 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S041) | Alcon Research, Ltd. | 2013-08-07 |
| INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER (P020025/S036) | Boston Scientific | 2013-08-07 |
| ENDOTAK LEAD FAMILY (P910073/S117) | Boston Scientific | 2013-08-07 |
| FREEZOR CARDIAC CRYOABLATION SYSTEM (P020045/S049) | Medtronic Cryocath, LP | 2013-08-07 |
| VENTAK PRX MINI (P910077/S133) | Boston Scientific | 2013-08-07 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S168) | Boston Scientific Corp | 2013-08-06 |
| LCS TOTAL KNEE SYSTEM (P830055/S132) | Depuy, Inc. | 2013-08-06 |
| ELECSYS ANTI-HBC IGM ASSAY (MODULAR ANALYTICS E170 ANALYZER) (P110025/S010) | Roche Diagnostics Corp. | 2013-08-06 |
| DEPUY CERAMAX TOTAL HIP SYSTEM (P070026/S012) | DePuy Orthopaedics, Inc. | 2013-08-06 |
| EXABLATE (P110039/S003) | Insightec | 2013-08-06 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S009) | DePuy Orthopaedics, Inc. | 2013-08-06 |
| SOF-FORM 55 EW, LL-55, SOFTCON EW 2 (P890040/S007) | Unilens Corp., USA | 2013-08-06 |
| BIOFINITY (P080011/S026) | CooperVision, Inc. | 2013-08-06 |
| ELECSYS ANTI-HBC IGM ASSAY (COBAS E 601 ANALYZER) (P110022/S011) | Roche Diagnostics Corp. | 2013-08-06 |
| REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S024) | Smith & Nephew, Inc. | 2013-08-06 |
| ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER) (P110031/S010) | Roche Diagnostics Corp. | 2013-08-06 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S029) | ABBOTT MEDICAL | 2013-08-05 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S031) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| GORE VIBAHN ENDOPROSTHESIS (P040037/S054) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S086) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| SYNCHROMED II AND SYNCHROMED EL DRUG PUMPS (P860004/S193) | Medtronic, Inc. | 2013-08-05 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S056) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S036) | W. L. Gore & Associates, Inc. | 2013-08-05 |