| AFX ENDOVASCULAR AAA SYSTEM (P040002/S047) | Endologix, LLC | 2014-12-31 |
| ENLITE GLUCOSE SENSORS (P120010/S048) | Medtronic, Inc. | 2014-12-31 |
| TECNIS 1-PIECE IOL, MODEL:ZCB00,TECNIS MULTIFOCAL 1-PIECE IOL, MODEL:ZMB00,TECNIS TORIC 1-PIECE IOL,MODELS:ZCT150, ZCT22 (P980040/S055) | Johnson & Johnson Surgical Vision, Inc. | 2014-12-31 |
| TRUMATCH SOLUTIONS (P830055/S152) | Depuy, Inc. | 2014-12-31 |
| ARCHITECT AUSAB PMA ASSAY (P050051/S029) | Abbott Laboratories, Inc. | 2014-12-30 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (P140010) | Medtronic, Inc. | 2014-12-30 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S033) | Zimmer, Inc. | 2014-12-30 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY PMA ASSAYS (P110029/S020) | Abbott Laboratories | 2014-12-30 |
| HER2 CISH PHARMDX KIT (P100024/S006) | Dako Denmark A/S | 2014-12-29 |
| MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) (P110002/S008) | Highridge Medical, LLC | 2014-12-29 |
| MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) (P110009/S008) | Highridge Medical, LLC | 2014-12-29 |
| ACCESS HYBRITECH PSA ASSAY (P850048/S038) | Beckman Coulter, Inc. | 2014-12-23 |
| ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S027) | Beckman Coulter, Inc. | 2014-12-23 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S012) | Beckman Coulter, Inc. | 2014-12-23 |
| ACCESS AFP IMMUNOASSAY SYSTEM (P980041/S028) | Beckman Coulter, Inc. | 2014-12-23 |
| BELLAFILL (P020012/S009) | Tiger Aesthetics Medical, LLC | 2014-12-23 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S402) | Medtronic, Inc. | 2014-12-23 |
| REPLY SR/ ESPRIT SR, REPLY DR/ ESPRIT DR FAMILY OF PACEMAKERS (P950029/S101) | MicroPort CRM USA, Inc. | 2014-12-23 |
| INTERSTIM THERAPY SYSTEM (P970004/S186) | Medtronic Neuromodulation | 2014-12-22 |
| THXID BRAF KIT (P120014/S002) | bioMerieux, Inc. | 2014-12-22 |
| ELECSYS HBSAG CONFIRMATORY TEST (P990012/S022) | Roche Diagnostics Corp. | 2014-12-22 |
| ENDURITY FAMILY OF PACEMEKERS (P880086/S248) | ABBOTT MEDICAL | 2014-12-22 |
| ALLURE AND ALLURE QUADRA FAMILY OF CRT-P'S (P030035/S126) | ABBOTT MEDICAL | 2014-12-22 |
| INTERSTIM THERAPY SYSTEM (P080025/S082) | Medtronic Neuromodulation | 2014-12-22 |
| VISIAN IMPLANTABLE COLLAMER LENSES (P030016/S027) | STAAR Surgical Company | 2014-12-22 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S212) | Medtronic, Inc. | 2014-12-22 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S009) | ABBOTT MEDICAL | 2014-12-22 |
| NEUROPACE RNS SYSTEM (P100026/S025) | NeuroPace, Inc. | 2014-12-22 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S286) | Medtronic Neuromodulation | 2014-12-22 |
| ELECSYS FREE PSA CALCHECK (P000027/S020) | Roche Diagnostics Corp. | 2014-12-22 |
| ELECSYS ANTI-HBS CALCHECK (P010054/S024) | Roche Diagnostics Corp. | 2014-12-22 |
| PRODISC -C TOTAL DISC REPLACEMENT (P070001/S012) | Centinel Spine, LLC | 2014-12-22 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, (P010031/S475) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS (P010012/S379) | Boston Scientific Corp | 2014-12-19 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S512) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| MELAFIND (P090012/S005) | Strata Skin Sciences, Inc. | 2014-12-19 |
| NU VASIVE PCM CERVICAL DISC SYSTEM (P100012/S006) | Nuvasive, Inc. | 2014-12-19 |
| ENDURANT, ENDURANT II, ENDURANT II AORTO -UNI-ILIAC (AUI) AND ENDURANT II'S STENT GRAFT SYSTEM (P100021/S043) | Medtronic Vascular | 2014-12-19 |
| MINIMED 530G SYSTEM (P120010/S047) | Medtronic, Inc. | 2014-12-19 |
| MAESTRO 4000 CARDIAC ABLATION SYSTEM (P020025/S060) | Boston Scientific | 2014-12-19 |
| EON TM, EONC TM, PROTEGE, PROTEGE MRI AND BRIO IMPLANTABLE PULSE GENERATOR (P010032/S088) | ABBOTT MEDICAL | 2014-12-19 |
| BRACANALYSIS CDX (P140020) | Myriad Genetic Laboratories | 2014-12-19 |
| MAESTRO 4000 CARDIAC ABLATION SYSTEM (P980003/S052) | Boston Scientific Corp | 2014-12-19 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S403) | Medtronic, Inc. | 2014-12-19 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S002) | QIAGEN GmbH | 2014-12-19 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S254) | Medtronic, Inc. | 2014-12-19 |
| REVO MRI IPG (P090013/S163) | Medtronic, Inc. | 2014-12-19 |
| EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC (P980016/S511) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S338) | Boston Scientific | 2014-12-19 |
| PARADIGM REAL-TIME INSULIN PUMP AND PARADIGM REAL TIME REVEL INSULIN PUMP (P980022/S173) | Medtronic Minimed | 2014-12-19 |
| ENDURANT, ENDURANT 11, ENDURANT IIS STENT GRAFT SYSTEM AND ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM (P100021/S044) | Medtronic Vascular | 2014-12-19 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D AND VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S476) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S202) | Boston Scientific Corp | 2014-12-19 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S054) | Medtronic | 2014-12-19 |
| MAESTRO 4000 CARDIAC ABLATION SYSTEM (P920047/S072) | Boston Scientific Corp | 2014-12-19 |
| REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTERS MECHANICAL HEART VALVE (P810002/S092) | ABBOTT MEDICAL | 2014-12-18 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S046) | Medtronic Vascular | 2014-12-18 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S058) | Integra LifeSciences Corporation | 2014-12-18 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S022) | Infusyn Therapeutics, LLC | 2014-12-18 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S100) | Boston Scientific Corp | 2014-12-18 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S111) | Boston Scientific Corp | 2014-12-18 |
| TRIPOLE 16/16C,EXCLAIM,LAMITRODE 4/44/44C/88/S-4/S8, PENTA,OCTRODE, AND QUATTRODE LEADS (P010032/S089) | ABBOTT MEDICAL | 2014-12-18 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- OVER THE WIRE; ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM-MONORAIL (P100023/S110) | Boston Scientific Corp | 2014-12-18 |
| OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S013) | Endologix, LLC | 2014-12-18 |
| HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S042) | CooperSurgical, Inc. | 2014-12-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S018) | Endologix, LLC | 2014-12-18 |
| LCS TOTAL KNEE SYSTEM (P830055/S153) | Depuy, Inc. | 2014-12-18 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S057) | Integra LifeSciences Corporation | 2014-12-18 |
| QUICK-CLOSE VASCULAR SUTURING SYSTEM (P080029/S002) | Cardiva Medical, Inc. | 2014-12-18 |
| GORE TAG THORACIC ENDOPROTHESIS (P040043/S070) | W. L. Gore & Associates, Inc. | 2014-12-17 |
| WAVE LIGHT EX500 LASER SYSTEM (P020050/S017) | Alcon Laboratories, Inc. | 2014-12-17 |
| BIOFINITY (COMFLICON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S032) | CooperVision, Inc. | 2014-12-17 |
| SUPARTZ (P980044/S023) | Seikagaku Corp. | 2014-12-17 |
| SUPARTZ (P980044/S021) | Seikagaku Corp. | 2014-12-17 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S058) | Intera Oncology | 2014-12-17 |
| WAVE LIGHT EX500 LASER SYSTEM (P030008/S015) | Alcon Laboratories, Inc. | 2014-12-17 |
| VNS THERAPY DEMIPULSE AND VNS THERAPY DEMIPULSE DUO (P970003/S175) | LivaNova USA, Inc. | 2014-12-17 |
| MITRACLIP DELIVERY SYSTEM (P100009/S008) | ABBOTT MEDICAL | 2014-12-17 |
| TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC P (P980040/S054) | Johnson & Johnson Surgical Vision, Inc. | 2014-12-17 |
| CHILLI II COOLED ABLATION SYSTEM (P980003/S055) | Boston Scientific Corp | 2014-12-17 |
| SUPARTZ (P980044/S022) | Seikagaku Corp. | 2014-12-17 |
| TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL) (P980040/S049) | Johnson & Johnson Surgical Vision, Inc. | 2014-12-17 |
| BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS (P920047/S075) | Boston Scientific Corp | 2014-12-17 |
| ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S019) | Abbott Laboratories | 2014-12-17 |
| BLAZER II XP TEMPERATURE ABLATION CATHETER (P020025/S065) | Boston Scientific | 2014-12-17 |
| SUPARTZ (P980044/S020) | Seikagaku Corp. | 2014-12-17 |
| PROLIEVE THERMODILATATION SYSTEM (P030006/S027) | Medifocus, Inc. | 2014-12-16 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S048) | Medtronic Vascular | 2014-12-16 |
| MEMORYSHAPE BREAST IMPLANTS (P060028/S004) | Mentor Worldwide, LLC | 2014-12-16 |
| MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS (P990075/S031) | Mentor Worldwide, LLC | 2014-12-16 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S012) | Glaukos Corporation | 2014-12-16 |
| PARADYM CRT-D 8750; PARADYM RF CRT-D 9750; PARADYM RF BCRT-D9750; INTENSIA CRT-D (P060027/S071) | MicroPort CRM USA, Inc. | 2014-12-16 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750; RF DR 9750; RF VR 9750; RF DR 9750; INTENSIA VR ICD, INTENSIA DR (P980049/S104) | MicroPort CRM USA, Inc. | 2014-12-16 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S074) | Spectranetics Corp. | 2014-12-16 |
| REPLY SR, REPLY DE, ESPRIT DR (P950029/S100) | MicroPort CRM USA, Inc. | 2014-12-16 |
| MENTOR MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS (P030053/S022) | Mentor Corp. | 2014-12-16 |
| REPLY/ESPRIT PACEMAKERS (P950029/S099) | MicroPort CRM USA, Inc. | 2014-12-15 |
| PROMOTE ACCEL, PROMOTE+ FAMILIES OF CRT-D DEVICES (P030054/S279) | ABBOTT MEDICAL | 2014-12-15 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S003) | Mentor Worldwide, LLC | 2014-12-15 |