| COLLASTAT/ INSTAT ABSORBALE COLLAGEN HEMOSTATIC AGENTS (P810006/S059) | Integra LifeSciences Corporation | 2015-03-20 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S029) | Edwards Lifesciences, LLC | 2015-03-20 |
| ACCESS HYBRITECH PSA ASSAY (P850048/S040) | Beckman Coulter, Inc. | 2015-03-20 |
| ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM (P090026/S014) | Beckman Coulter, Inc. | 2015-03-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S053) | Edwards Lifesciences, LLC | 2015-03-20 |
| RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S294) | Medtronic Neuromodulation | 2015-03-20 |
| MINIMED 530G SYSTEM (P120010/S056) | Medtronic, Inc. | 2015-03-20 |
| ACCESS AFP IMMUNOASSAY SYSTEM (P980041/S030) | Beckman Coulter, Inc. | 2015-03-20 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S066) | Edwards Lifesciences, LLC | 2015-03-20 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S218) | Medtronic, Inc. | 2015-03-20 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S010) | Cardiva Medical, Inc. | 2015-03-20 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S040) | W. L. Gore & Associates, Inc. | 2015-03-20 |
| STRATOS LV/LV-T, EVIA HF/HF-T, ENTOVIS HF/HF-T CRT-P'S (P070008/S057) | Biotronik, Inc. | 2015-03-19 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S104) | MicroPort CRM USA, Inc. | 2015-03-19 |
| ENTOVIS DR-T,DR,SR-T,SR; ELUNA 8 DR-T PROMRI,DR PROMRI,SR-T PRMRI,SR PROMRI;SETROX S53,S60;SAFIO S53,S60 (P950037/S142) | Biotronik, Inc. | 2015-03-19 |
| ACUITY SPIRAL LEADS (P010012/S383) | Boston Scientific Corp | 2015-03-19 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S534) | Medtronic Cardiac Rhythm Disease Management | 2015-03-19 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S008) | Mentor Worldwide, LLC | 2015-03-19 |
| PARADYM (VR/DR) 8750, PARADYM RF (VR/DR) 9750(ZL101),PARADYM RF (VR/DR) 9750 (ZL102),INTENSIA (VR/DR) (P980049/S108) | MicroPort CRM USA, Inc. | 2015-03-19 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S021) | Ventana Medical Systems, Inc. | 2015-03-19 |
| EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHETER (P950005/S056) | Biosense Webster, Inc. | 2015-03-19 |
| BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S060) | Biotronik, Inc. | 2015-03-19 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S046) | W. L. Gore & Associates, Inc. | 2015-03-19 |
| THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS (P040036/S049) | Biosense Webster, Inc. | 2015-03-19 |
| ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S056) | Alcon Research, Ltd. | 2015-03-19 |
| EZ STEER NAV BI-DIRECTIONAL CATHETER AND NAVISTAR CATHETER (P990025/S044) | Biosense Webster, Inc. | 2015-03-19 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D 9750 (ZL 102) AND INTENSIA CRT-D (P060027/S075) | MicroPort CRM USA, Inc. | 2015-03-19 |
| IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S (P050023/S081) | Biotronik, Inc. | 2015-03-19 |
| EZ STEER NAV DS BI-DIRECTIONAL CATHETERS (P010068/S045) | Biosense Webster, Inc. | 2015-03-19 |
| ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (P110028/S015) | Abbott Vascular, Inc. | 2015-03-19 |
| THERAKOS CELLEXPHOTOPHERESIS SYSTEM (P860003/S078) | Therakos Development Limited | 2015-03-19 |
| ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995 (P980035/S374) | Medtronic, Inc. | 2015-03-19 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S498) | Medtronic Cardiac Rhythm Disease Management | 2015-03-19 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S062) | Hologic, Inc. | 2015-03-19 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S078) | Alcon Laboratories, Inc. | 2015-03-19 |
| EZ STEER AND THERMOCOOL CATHETER FAMILIES (P030031/S066) | Biosense Webster, Inc. | 2015-03-19 |
| ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY (P910073/S129) | Boston Scientific | 2015-03-19 |
| DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS) (P130005/S006) | Cardiovascular Systems, Inc. | 2015-03-18 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATIONAL CATHETER (P030031/S065) | Biosense Webster, Inc. | 2015-03-18 |
| THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATIONAL CATHETER (P040036/S048) | Biosense Webster, Inc. | 2015-03-18 |
| CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S024) | DePuy Orthopaedics, Inc. | 2015-03-18 |
| NIRXCELL COCR CORONARY STENT ON RX (P110004/S011) | Medinol, Ltd. | 2015-03-17 |
| TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM (P980040/S056) | Johnson & Johnson Surgical Vision, Inc. | 2015-03-17 |
| EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS (P980016/S533) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S007) | Mentor Worldwide, LLC | 2015-03-17 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE USP (P990004/S026) | Ferrosan Meidcal Devices A/S | 2015-03-17 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR (P980049/S106) | MicroPort CRM USA, Inc. | 2015-03-17 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE USP (P990004/S027) | Ferrosan Meidcal Devices A/S | 2015-03-17 |
| MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S024) | Mentor Corp. | 2015-03-17 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S103) | MicroPort CRM USA, Inc. | 2015-03-17 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S497) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, (P980016/S531) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S010) | Boston Scientific Corp | 2015-03-17 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S114) | Boston Scientific Corp | 2015-03-17 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S103) | Boston Scientific Corp | 2015-03-17 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (ZL 102), INTENSIA CRT-D (P060027/S073) | MicroPort CRM USA, Inc. | 2015-03-17 |
| NOVA TTF-100A SYSTEM (P100034/S011) | Novocure, GmbH | 2015-03-17 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S066) | Boston Scientific Corp | 2015-03-17 |
| BRAVA , BRAVA QUAD/S , VIVA QUAD S/XT ,, VIVA S/XT CRT-D'S (P010031/S495) | Medtronic Cardiac Rhythm Disease Management | 2015-03-17 |
| ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R (P050038/S023) | Davol, Inc. | 2015-03-16 |
| PROGEL PLEURAL AIR LEAK SEALANT AND PROGEL EXTENDED APPLICATOR SPRAY TIP (P010047/S037) | Neomend, Inc. | 2015-03-16 |
| NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S009) | Allergan | 2015-03-13 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S011) | Cochlear Americas | 2015-03-13 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S214) | Boston Scientific Corp | 2015-03-13 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S128) | Cochlear Americas | 2015-03-13 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S031) | Allergan | 2015-03-13 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013) | Boston Scientific Corp | 2015-03-13 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S027) | Allergan | 2015-03-13 |
| EMBLEM S ICD SYSTEM (P110042/S043) | Boston Scientific Corporation | 2015-03-13 |
| PARADYM (VR/DR) 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF (VR/DR) 9750,INTENSIA (VR 124/DR 154) (P980049/S107) | MicroPort CRM USA, Inc. | 2015-03-13 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174 (P060027/S074) | MicroPort CRM USA, Inc. | 2015-03-13 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S022) | Ferring Pharmaceuticals, Inc. | 2015-03-12 |
| CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S026) | DePuy Orthopaedics, Inc. | 2015-03-12 |
| MED-EL COCHLEAR IMPLANT SYSTEM (P000025/S081) | Med-El Corp. | 2015-03-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR (P010021/S025) | Ortho-Clinical Diagnostics, Inc. | 2015-03-11 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D (P010031/S496) | Medtronic Cardiac Rhythm Disease Management | 2015-03-11 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S009) | Cardiva Medical, Inc. | 2015-03-11 |
| CAPSUREFIX NOVUS LEAD (P930039/S126) | Medtronic, Inc. | 2015-03-11 |
| BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL (P080011/S035) | CooperVision, Inc. | 2015-03-11 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S532) | Medtronic Cardiac Rhythm Disease Management | 2015-03-11 |
| ATTAIN STARFIX LEAD (P060039/S065) | Medtronic, Inc. | 2015-03-11 |
| CAPSUREFIX MRI LEAD (P090013/S178) | Medtronic, Inc. | 2015-03-11 |
| ACRYSOF ASPHERIC UV ABSORBING INTRAOCULAR LENSES (IOLS) (P930014/S076) | Alcon Laboratories, Inc. | 2015-03-10 |
| ADVIA CENTAUR HCV READYPACKS (P030056/S008) | Siemens Healthcare Diagnostics | 2015-03-10 |
| NEUROPACE RNS SYSTEM (P100026/S026) | NeuroPace, Inc. | 2015-03-10 |
| ZIMMER NEXGEN LPS-FLEX AND LPS MOBILE BEARING KNEES (P060037/S032) | Zimmer, Inc. | 2015-03-10 |
| CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S025) | DePuy Orthopaedics, Inc. | 2015-03-10 |
| GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX) (P040013/S020) | Lynch Biologics, LLC | 2015-03-09 |
| EXPRESS LD ILIAC PREMOUNTEDSTENT SYSTEM (P090003/S038) | Boston Scientific Corporation | 2015-03-06 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S293) | Medtronic Neuromodulation | 2015-03-06 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S009) | Bolton Medical, Inc. | 2015-03-06 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S007) | Abbott Vascular (Idef Technologies Inc) | 2015-03-06 |
| NEUROPACE RNS SYSTEM (P100026/S030) | NeuroPace, Inc. | 2015-03-06 |
| RESQCPR SYSTEM (P110024) | ZOLL Medical Corporation | 2015-03-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S030) | Boston Scientific Corp | 2015-03-06 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S217) | Medtronic, Inc. | 2015-03-06 |
| INTERSTIM THERAPY SYSTEM (P970004/S190) | Medtronic Neuromodulation | 2015-03-06 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S065) | Boston Scientific Corp | 2015-03-06 |
| INTERSTIM THERAPY SYSTEM (P080025/S086) | Medtronic Neuromodulation | 2015-03-06 |
| NATRELLE SILICONE-FILLED BREST IMPLANTS (P020056/S018) | Allergan | 2015-03-05 |