| FREESTYLE AORTIC ROOT BIOPROSTHESIS(MODELS 995, 995CS, 995MS) (P970031/S048) | Medtronic, Inc. | 2014-11-12 |
| NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S008) | Allergan | 2014-11-07 |
| MEDTRONIC MODELS 2490H CARELINK REMOTE HOME MONITOR, 2020C CARELINK EXPRESS MONITOR, AND 2491 DDMA (P890003/S319) | Medtronic, Inc. | 2014-11-07 |
| MYCARELINK PATIENT MONITOR (P890003/S320) | Medtronic, Inc. | 2014-11-07 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD, INTRINSIC ICD, MARQUIS ICD,MARQUIS V (P980016/S500) | Medtronic Cardiac Rhythm Disease Management | 2014-11-07 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI (P010031/S464) | Medtronic Cardiac Rhythm Disease Management | 2014-11-07 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP (P980035/S392) | Medtronic, Inc. | 2014-11-07 |
| REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR (P950029/S098) | MicroPort CRM USA, Inc. | 2014-11-07 |
| DYNAGEN EL, INOGEN EL, ORIGEN EL ICDS (P960040/S332) | Boston Scientific | 2014-11-07 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S003) | Abbott Vascular (Idef Technologies Inc) | 2014-11-07 |
| INTENSIA VR 124, INTENSIA DR 154, INTENSIA CRT-D 174 (P980049/S103) | MicroPort CRM USA, Inc. | 2014-11-07 |
| ADAPTA, VERSA, SENSIA, ENPULSE E1/E2. KAPPA D/DR/VDD IPG'S (P980035/S391) | Medtronic, Inc. | 2014-11-07 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S248) | Medtronic, Inc. | 2014-11-07 |
| DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 CRT-D (P010012/S371) | Boston Scientific Corp | 2014-11-07 |
| REVO MRI IPG (P090013/S154) | Medtronic, Inc. | 2014-11-07 |
| PARADYM VR 8250, PARADYM DR 8550, PARADYM CRT-D 8750, PARADYM RF VR 9250, PARADYM RF DR 9550, PARADYM M RF CRT-D 9750 (P060027/S070) | MicroPort CRM USA, Inc. | 2014-11-07 |
| LIVEWIRE TC AND SAFIRE BIDIRECTIONAL ABLATION CATHETER (P960016/S049) | St Jude Medical | 2014-11-06 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S004) | Inspire Medical Systems | 2014-11-06 |
| DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES, DEXTRUS, SETROX, TILDA, SAFIO (P950037/S143) | Biotronik, Inc. | 2014-11-06 |
| PARADYM RF VR 9250 PARADYM RF DR 9550 (P980049/S102) | MicroPort CRM USA, Inc. | 2014-11-06 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S100) | Boston Scientific Corp | 2014-11-06 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S004) | Cardiva Medical, Inc. | 2014-11-06 |
| LATITUDE CONSULT SYSTEM (P910077/S147) | Boston Scientific | 2014-11-06 |
| THE COOL POINT IRRIGATION PUMP (P060019/S029) | Irvine Biomedical, Inc. | 2014-11-06 |
| PARADYM RF CRT-D9750 (P060027/S069) | MicroPort CRM USA, Inc. | 2014-11-06 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S019) | Cerenovus, Inc. | 2014-11-05 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S109) | Boston Scientific Corp | 2014-11-05 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S032) | Medtimo, Inc. | 2014-11-05 |
| PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S098) | Boston Scientific Corp | 2014-11-05 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S038) | Coloplast Corp. | 2014-11-04 |
| GELFOAM PLUS HEMOSTATS KITS (N18286/S027) | Pfizer, Inc. | 2014-11-04 |
| INTENSIA CRT-D (P060027/S066) | MicroPort CRM USA, Inc. | 2014-11-04 |
| ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS (P910073/S128) | Boston Scientific | 2014-11-04 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S030) | Allergan | 2014-11-04 |
| PIPELINE EMBOLIZATION DEVICE (P100018/S013) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-11-04 |
| INSTENSIA ICD (P980049/S099) | MicroPort CRM USA, Inc. | 2014-11-04 |
| SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S003) | Scott Laboratories, Inc. | 2014-11-03 |
| SILICOM(TM) 1000 RETINALTAMPONADE (P950008/S012) | Alcon | 2014-11-03 |
| COLLACOTE AND COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S036) | Integra Lifesciences Corp. | 2014-10-31 |
| HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S047) | Integra LifeSciences Corporation | 2014-10-31 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049/S004) | LeMaitre Vascular, Inc. | 2014-10-31 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P810006/S049) | Integra LifeSciences Corporation | 2014-10-31 |
| PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S097) | Boston Scientific Corp | 2014-10-30 |
| ACE HEADER (P900061/S132) | Medtronic Cardiac Rhythm Disease Management | 2014-10-30 |
| GEL-ONE (P080020/S013) | Seikagaku Corp. | 2014-10-30 |
| ATTAIN PERFORMA QUADRIPOLAR LEAD (P080006/S075) | Medtronic, Inc. | 2014-10-30 |
| TUNNELING TOOL (P920015/S145) | Medtronic, Inc. | 2014-10-30 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S006) | Boston Scientific Corp | 2014-10-30 |
| ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S397) | Medtronic, Inc. | 2014-10-30 |
| SPECTRANETICS LASER SHEATH SLS (P960042/S050) | Spectranetics (Philips) | 2014-10-30 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S108) | Boston Scientific Corp | 2014-10-30 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S108) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S043) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| AMPLATZER VSD MUSCULAR OCCLUDER (P040040/S022) | ABBOTT MEDICAL | 2014-10-29 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER CRIBIFORM OCCLUDER (P000039/S048) | ABBOTT MEDICAL | 2014-10-29 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S013) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S020) | Mentor Corp. | 2014-10-29 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S038) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S073) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S069) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S106) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| ARCHITECT AUSAB (LN 1L82) (P050051/S027) | Abbott Laboratories, Inc. | 2014-10-29 |
| DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S001) | Cardiovascular Systems, Inc. | 2014-10-29 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S032) | Allergan | 2014-10-29 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S028) | Allergan | 2014-10-29 |
| VISCOAT,DUOVISC,DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S057) | Alcon Laboratories | 2014-10-29 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S011) | Allergan | 2014-10-29 |
| AMPLATZER DUCT OCCLUDER (ADO) (P020024/S038) | ABBOTT MEDICAL | 2014-10-29 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S044) | Alcon Research, Ltd. | 2014-10-29 |
| MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS (P990075/S027) | Mentor Worldwide, LLC | 2014-10-29 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S109) | W. L. Gore & Associates, Inc. | 2014-10-29 |
| MEMORYSHAPE BREAST IMPLANTS (P060028/S002) | Mentor Worldwide, LLC | 2014-10-29 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S054) | Boston Scientific Corp | 2014-10-28 |
| AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE (P110032/S009) | Lombard Medical Limited | 2014-10-28 |
| DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S335) | Boston Scientific | 2014-10-28 |
| NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM (P010013/S058) | Hologic, Inc. | 2014-10-28 |
| ADVIA CENTAUR HBSAG (HBS) ASSAY (P030049/S011) | Siemens Healthcare Diagnostics | 2014-10-28 |
| INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S040) | Integra Lifesciences Corp. | 2014-10-28 |
| DYNAGEN, INOGEN, ORGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S374) | Boston Scientific Corp | 2014-10-28 |
| ON-X PROSTHETIC HEART VALVE (P000037/S036) | On-X Life Technologies, Inc. | 2014-10-28 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S087) | ABBOTT MEDICAL | 2014-10-27 |
| RADIESSE DERMAL FILLER (P050052/S055) | Merz North America, Inc. | 2014-10-24 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S029) | Beckman Coulter, Inc. | 2014-10-24 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S013) | Beckman Coulter, Inc. | 2014-10-24 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S028) | Beckman Coulter, Inc. | 2014-10-24 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S072) | W. L. Gore & Associates, Inc. | 2014-10-24 |
| RADIESSE DERMAL FILLER (P050037/S050) | Merz North America, Inc. | 2014-10-24 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S126) | Abbott Vascular, Inc. | 2014-10-24 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), XIENCE XPEDITION EVEROLIMUS ELUTING (P110019/S073) | Abbott Vascular | 2014-10-24 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S039) | Beckman Coulter, Inc. | 2014-10-24 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S060) | Abbott Vascular | 2014-10-24 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S012) | W. L. Gore & Associates, Inc. | 2014-10-24 |
| X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM (P040001/S022) | Medtronic Sofamor Danek, Inc. | 2014-10-24 |
| TACTICATH QUARTZ SET (P130026) | St Jude Medical | 2014-10-24 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S026) | Medifocus, Inc. | 2014-10-24 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S203) | Medtronic, Inc. | 2014-10-24 |
| PRODIGY IPG (P890003/S324) | Medtronic, Inc. | 2014-10-23 |
| ENDURANT IIS STENT GRAFT SYSTEM (P100021/S039) | Medtronic Vascular | 2014-10-23 |
| CORDIS SMART/ SMART CONTROL NITINOL STENT SYSTEM (P020036/S030) | Cordis US Corporation | 2014-10-23 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S006) | Cardiva Medical, Inc. | 2014-10-23 |