| SHARPS TERMINATOR (P120018) | Sharps Terminator, LLC | 2016-02-17 |
| QUICKFLEX U AND QUARTET CRT LEADS (P030054/S298) | ABBOTT MEDICAL | 2016-02-17 |
| IsoFlex Models 1642T, 1646T, 1944, 1948 (P960030/S042) | ABBOTT MEDICAL | 2016-02-17 |
| EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI (P010032/S111) | ABBOTT MEDICAL | 2016-02-17 |
| ISOFLEX OPTIM LV LEADS (P960030/S041) | ABBOTT MEDICAL | 2016-02-17 |
| QuickFlex u Model 1258T (P030054/S299) | ABBOTT MEDICAL | 2016-02-17 |
| TRULIGN TORIC WEB BASED TORIC CALCULATOR (P030002/S036) | Bausch & Lomb, Inc. | 2016-02-17 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S002) | Nuvectra Corporation | 2016-02-17 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S046) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S048) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S047) | Edwards Lifesciences, LLC | 2016-02-16 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIMUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATIN (P110010/S116) | Boston Scientific Corp | 2016-02-16 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S008) | Edwards Lifesciences, LLC | 2016-02-16 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S123) | Boston Scientific Corp | 2016-02-16 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S017) | Boston Scientific Corp | 2016-02-16 |
| OPEN PIVOT HEART VALVE, OPEN PIVOT AORTIC VALVED GRAFT, OPEN PIVOT HEART VALVE-APEX, OPEN PIVOT HEART VALVE-AP360 (P990046/S042) | Medtronic Ats Medical, Inc. | 2016-02-12 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S094) | St. Jude Medical, Inc. | 2016-02-12 |
| LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S027) | Lenstec, Inc. | 2016-02-12 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S007) | Reshape Lifesciences, Inc. | 2016-02-12 |
| MEMORYGEL BREAST IMPLANT (P030053/S031) | Mentor Corp. | 2016-02-12 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S138) | ABBOTT MEDICAL | 2016-02-12 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S066) | ABBOTT MEDICAL | 2016-02-12 |
| BD PREPSTAIN SYSTEM (P970018/S032) | Bd Diagnostic Systems | 2016-02-12 |
| ANGIOJET ULTRA THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY, ANGIOJ (P980037/S056) | Boston Scientific Corp | 2016-02-12 |
| VNS THERAPY SYSTEM (P970003/S170) | LivaNova USA, Inc. | 2016-02-12 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S291) | ABBOTT MEDICAL | 2016-02-12 |
| MEMORYSHAPE BREAST IMPLANTS (P060028/S013) | Mentor Worldwide, LLC | 2016-02-12 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S260) | ABBOTT MEDICAL | 2016-02-12 |
| BD FOCALPOINT SLIDE PROFILER (P950009/S018) | Bd Diagnostics | 2016-02-12 |
| ATTAIN ABILITY LEAD Models 4196, 4296, 4396 (P080006/S088) | Medtronic, Inc. | 2016-02-12 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S083) | Spectranetics Corp. | 2016-02-12 |
| CLOSER VASCULAR SEALING SYSTEM (P150022) | Rex Medical, L.P. | 2016-02-12 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S018) | Boston Scientific Corp | 2016-02-12 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S361) | ABBOTT MEDICAL | 2016-02-12 |
| BD TOTALYS SLIDEPREP (P970018/S030) | Bd Diagnostic Systems | 2016-02-12 |
| SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S011) | Scott Laboratories, Inc. | 2016-02-12 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG (P980035/S453) | Medtronic, Inc. | 2016-02-11 |
| Axium Neurostimulator System (P150004) | ABBOTT MEDICAL | 2016-02-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S081) | W. L. Gore & Associates, Inc. | 2016-02-11 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S045) | Edwards Lifesciences, LLC | 2016-02-10 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S006) | Edwards Lifesciences, LLC | 2016-02-10 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S019) | Cardiva Medical, Inc. | 2016-02-10 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET; ANGIOJET ULTRA SPIROFLEX & SPIROFLEX VG THROMBECTOMY SET; ANGIOLET ULTRA DISTAFLEX (P980037/S055) | Boston Scientific Corp | 2016-02-10 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS. RSR PERICARDIAL AORTIC BIOPROSTHESIS, MAGNA PERICARDIAL A (P860057/S141) | Edwards Lifesciences, LLC | 2016-02-10 |
| coflex Interlaminar Technology (P110008/S004) | Companion Spine France | 2016-02-09 |
| CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (P030002/S037) | Bausch & Lomb, Inc. | 2016-02-09 |
| COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 (P060030/S049) | Roche Molecular Systems, Inc. | 2016-02-09 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S024) | Roche Molecular Systems, Inc. | 2016-02-09 |
| SOLO SMART STENTLESS HEART VALVE (SOLO SMART) (P130011/S002) | Corcym Canada Corp | 2016-02-09 |
| STAR EXCIMER LASER SYSTEM (P930016/S047) | Amo Manufacturing USA, LLC | 2016-02-09 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S070) | Zoll Manufacturing Corporation | 2016-02-09 |
| NOVOCURE'S OPTUNE SYSTEM (P100034/S014) | Novocure, GmbH | 2016-02-09 |
| DISPOSABLE FALOPE-RING BANK APPLICATOR KITS (P870076/S020) | Gyrus Acmi, Inc. | 2016-02-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S048) | Roche Molecular Systems, Inc. | 2016-02-09 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S070) | Medtronic | 2016-02-09 |
| SPRINT QUATTRO LEAD ; SPRINT QUATTRO LEAD (P920015/S173) | Medtronic, Inc. | 2016-02-09 |
| CHILLI II COOLED ABLATION SYSTEM (P920047/S083) | Boston Scientific Corp | 2016-02-08 |
| CHILLI II COOLED ABLATION SYSTEM (P020025/S076) | Boston Scientific | 2016-02-08 |
| OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S041) | Medtronic Ats Medical, Inc. | 2016-02-08 |
| PROMOTE+UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DIVICES (P030054/S297) | ABBOTT MEDICAL | 2016-02-08 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S036) | Medtimo, Inc. | 2016-02-08 |
| CHILLI II COOLED ABLATION SYSTEM (P980003/S061) | Boston Scientific Corp | 2016-02-08 |
| CURRENT+ FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES (P910023/S367) | ABBOTT MEDICAL | 2016-02-08 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S049) | W. L. Gore & Associates, Inc. | 2016-02-08 |
| INVIVE, INTUA, VISIONIST, VALITUDE CRT-P RESYNCHRONIZATION DEVICES (P030005/S131) | Guidant Corp. | 2016-02-05 |
| SPECIFY SURESCAN MRI 5-6-5 LEAD 65 CM, SPECIFY SURESCAN MRI 5-6-5 LEAD 90 CM, SPECIFY SURESCAN MRI 2X8 LEAD 65 CM, SPECI (P840001/S308) | Medtronic Neuromodulation | 2016-02-05 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE, USP (P990004/S028) | Ferrosan Meidcal Devices A/S | 2016-02-05 |
| EVERA S DR,S VR XT DR, XT VE,ICD'S; MAXIMO II ICD,. PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S561) | Medtronic Cardiac Rhythm Disease Management | 2016-02-05 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES (P960040/S362) | Boston Scientific | 2016-02-05 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S014) | Mentor Worldwide, LLC | 2016-02-05 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, CRT-D RESYNCHRONIZATION DEVICES (P010012/S408) | Boston Scientific Corp | 2016-02-05 |
| ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE (N970003/S184) | Boston Scientific Corp | 2016-02-05 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S042) | Dexcom, Inc. | 2016-02-05 |
| LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460 (P910077/S151) | Boston Scientific | 2016-02-05 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S142) | Cochlear Americas | 2016-02-05 |
| NEUROPACE RNS SYSTEM (P100026/S041) | NeuroPace, Inc. | 2016-02-05 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S015) | Cochlear Americas | 2016-02-05 |
| BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD C, S AND XT, VIVA S, VIVA XT CRT-D (P010031/S522) | Medtronic Cardiac Rhythm Disease Management | 2016-02-05 |
| RAPID FFN FOR THE TLIIQ SYSTEM (P920048/S011) | Hologic, Inc. | 2016-02-05 |
| MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR (P890003/S344) | Medtronic, Inc. | 2016-02-05 |
| EMBLEM (SUBCUTANEOUS ICD DEVICES) (P110042/S057) | Boston Scientific Corporation | 2016-02-05 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIMUM CORONARY STENT SYSTEM MONORAIL & OVER-THE-WIRE. (P150003/S004) | Boston Scientific Corporation | 2016-02-04 |
| RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE SILK, RESTYLANE LYFT, INJECTABLE GELS. (P040024/S086) | Q-Med AB | 2016-02-04 |
| AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S056) | Boston Scientific Corp | 2016-02-04 |
| AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS) (P010020/S029) | Boston Scientific Corp | 2016-02-04 |
| PRODISC-L TOTAL DISC REPLACEMENT (P050010/S017) | Centinel Spine, LLC | 2016-02-04 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S014) | Cochlear Americas | 2016-02-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S027) | W. L. Gore & Associates, Inc. | 2016-02-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S088) | W. L. Gore & Associates, Inc. | 2016-02-04 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S105) | Boston Scientific Corp | 2016-02-04 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S141) | Cochlear Americas | 2016-02-04 |
| COLOGUARD (P130017/S006) | Exact Sciences Corporation | 2016-02-04 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S111) | Boston Scientific Corp | 2016-02-03 |
| VALITUDE , VALITUDE X4 CRT-PS (P030005/S132) | Guidant Corp. | 2016-02-03 |
| ESSENTIO; PROPONENT; ACCOLADE ; ALTRUA 2 PACEMAKERS (N970003/S185) | Boston Scientific Corp | 2016-02-03 |
| DURASEAL (R) EXACT SPINE SEALANT SYSTEM (P080013/S012) | Integra LifeSciences Corporation | 2016-02-03 |
| SPRINT QUATTRO LEADS (P920015/S171) | Medtronic, Inc. | 2016-02-02 |
| ATTAIN ABILITY MRI , PLUS MRI,STRAIGHT MRI SURESCAN; ATTAIN PERFORMA MRI, STRAIGHT ANS S MRI SURESCAN (P080006/S085) | Medtronic, Inc. | 2016-02-01 |
| CAPSUREFIX NOVUS MRI SURESCAN (P930039/S140) | Medtronic, Inc. | 2016-02-01 |
| SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN (P920015/S163) | Medtronic, Inc. | 2016-02-01 |