| OL1000, OL1000 SC, SPINALOGIC (P910066/S027) | Djo, LLC | 2015-07-24 |
| RADIESSE (P050052/S068) | Merz North America, Inc. | 2015-07-24 |
| IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER (P140010/S007) | Medtronic, Inc. | 2015-07-24 |
| TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080010/S011) | Johnson & Johnson Surgical Vision, Inc. | 2015-07-24 |
| RADIESSE (P050037/S060) | Merz North America, Inc. | 2015-07-24 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S014) | Torax Medical | 2015-07-24 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S002) | Reshape Lifesciences, Inc. | 2015-07-24 |
| COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S022) | Roche Molecular Systems, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S008) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C (P890055/S060) | Intera Oncology | 2015-07-23 |
| ROCHE COBAS DNA SAMPLE PREPARATION KIT, ROCHE COBAS 4800 BRAF V600 MUTATION TEST (P110020/S014) | Roche Molecular Systems, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S022) | Ortho-Clinical Diagnostics | 2015-07-23 |
| ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P120019/S008) | Roche | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S026) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| COAPTITE (P040047/S041) | Merz North America, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S007) | Ortho-Clinical Diagnostics | 2015-07-23 |
| NEUROPACE RNS SYSTEM (P100026/S037) | NeuroPace, Inc. | 2015-07-23 |
| MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER (P100009/S012) | ABBOTT MEDICAL | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S030) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P140023/S001) | Roche Molecular Systems, Inc. | 2015-07-23 |
| COBAS TAQMAN HBV TEST, HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT (P050028/S047) | Roche Molecular Systems, Inc. | 2015-07-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S031) | Ortho-Clinical Diagnostics, Inc. | 2015-07-23 |
| BD FOCALPOINT SLIDE PROFILER (P950009/S019) | Bd Diagnostics | 2015-07-23 |
| COBAS HPC TEST,240 TESTS AND COBAS HPV TEST, 960 TESTS (P100020/S015) | Roche Molecular Systems, Inc. | 2015-07-23 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE (P060037/S037) | Zimmer, Inc. | 2015-07-23 |
| ENLITE GLUCOSE SENSORS (P120010/S068) | Medtronic, Inc. | 2015-07-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S119) | W. L. Gore & Associates, Inc. | 2015-07-22 |
| SOLO SMART STENTLESS HEART VALVE (P130011/S001) | Corcym Canada Corp | 2015-07-22 |
| TELIGEN,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN ICDS (P960040/S345) | Boston Scientific | 2015-07-21 |
| INVIVE,INTUA,VISIONIST,VALITUDE CRT-PS (P030005/S122) | Guidant Corp. | 2015-07-21 |
| NOVAFLEX DELIVERY SYSTEM (P130009/S016) | Edwards Lifesciences, LLC | 2015-07-21 |
| ADVANTIO,INGENIO,VITALIO,FORMIO,ESSENTIO,ACCOLADE,PROPONENT PACEMAKERS (N970003/S175) | Boston Scientific Corp | 2015-07-21 |
| LATITUDE NXT PATIENT MANAGEMENT SYSTEM (P910077/S149) | Boston Scientific | 2015-07-21 |
| EMBLEM SUBCUTANEOUS ICD (P110042/S045) | Boston Scientific Corporation | 2015-07-21 |
| COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS (P010012/S387) | Boston Scientific Corp | 2015-07-21 |
| GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S016) | Glaukos Corporation | 2015-07-21 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S021) | ETHICON, Inc. | 2015-07-21 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028) | Boston Scientific Corporation | 2015-07-21 |
| ACRYSOF IQ SINGLE-PIECE IOL WITH THE ACRYSERT C DELIVERY SYSTME (P930014/S080) | Alcon Laboratories, Inc. | 2015-07-20 |
| VALITUDE CRT-PS (P030005/S126) | Guidant Corp. | 2015-07-20 |
| ALTURA 2, ESSENTIO, PROPONENT AND ACCOLADE (N970003/S178) | Boston Scientific Corp | 2015-07-20 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S429) | Medtronic, Inc. | 2015-07-20 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S013) | Torax Medical | 2015-07-20 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S430) | Medtronic, Inc. | 2015-07-20 |
| 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/S504) | Medtronic Cardiac Rhythm Disease Management | 2015-07-20 |
| VALITUDE AND VALITUDE X4 CRT-P (P030005/S125) | Guidant Corp. | 2015-07-20 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S179) | Boston Scientific Corp | 2015-07-20 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S540) | Medtronic Cardiac Rhythm Disease Management | 2015-07-20 |
| REVO MRI SURESCAN IPG (P090013/S192) | Medtronic, Inc. | 2015-07-20 |
| LATITUDE INDUCTIVE COMMUNICATOR ; LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) (P910077/S150) | Boston Scientific | 2015-07-20 |
| REVO MRI SURESCAN IPG (P090013/S190) | Medtronic, Inc. | 2015-07-20 |
| OVATION IX ABDOMINAL STENT GRAFT SYSTEM (P120006/S020) | Endologix, LLC | 2015-07-17 |
| COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE (P130023/S001) | Cohera Medical, Inc. | 2015-07-17 |
| COROX OTW 75-UP STEROID,COROX OTW 85 UP STEROID (P050023/S084) | Biotronik, Inc. | 2015-07-17 |
| CAPESUREFIX LEAD, CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S133) | Medtronic, Inc. | 2015-07-17 |
| SLX 58/11-BP, SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,SLX 65/11-BP,SLX 65/13-BP,SLX 65/14-BP,SLX 65/15-BP,SL (P950037/S149) | Biotronik, Inc. | 2015-07-17 |
| KAINOX VCS,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65 (P980023/S065) | Biotronik, Inc. | 2015-07-17 |
| CAPSUREFIX MRI LEAD (P090013/S188) | Medtronic, Inc. | 2015-07-17 |
| ZIMMER NEXGEN LPS-MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S036) | Zimmer, Inc. | 2015-07-17 |
| PROTEGO (S/SD/T/TD) ICD LEAD (P980023/S071) | Biotronik, Inc. | 2015-07-17 |
| COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP (P070008/S061) | Biotronik, Inc. | 2015-07-17 |
| SPRINT QUATTRO LEAD (P920015/S157) | Medtronic, Inc. | 2015-07-17 |
| INTERSTIM THERAPY SYSTEM (P970004/S202) | Medtronic Neuromodulation | 2015-07-16 |
| EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD (P010012/S391) | Boston Scientific Corp | 2015-07-16 |
| RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S306) | Medtronic Neuromodulation | 2015-07-16 |
| VALITUDE, VALITUDE X4 CRT-PS (P030005/S124) | Guidant Corp. | 2015-07-16 |
| RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S307) | Medtronic Neuromodulation | 2015-07-16 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S135) | Medtronic, Inc. | 2015-07-16 |
| SUPARTZ FX (P980044/S026) | Seikagaku Corp. | 2015-07-16 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S177) | Boston Scientific Corp | 2015-07-16 |
| GEL-ONE (P080020/S015) | Seikagaku Corp. | 2015-07-16 |
| SYNCHROMED INFUSION SYSTEM (P860004/S232) | Medtronic, Inc. | 2015-07-16 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S233) | Medtronic, Inc. | 2015-07-16 |
| ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS (P910073/S130) | Boston Scientific | 2015-07-16 |
| SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM (P970004/S201) | Medtronic Neuromodulation | 2015-07-16 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S234) | Medtronic, Inc. | 2015-07-16 |
| FINELINE 2 PACING LEADS (P960004/S070) | Boston Scientific | 2015-07-16 |
| SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S008) | Scott Laboratories, Inc. | 2015-07-16 |
| ACUITY STEERABLE CORONARY SINUS PACING LEADS (P050046/S026) | Guidant Corp. | 2015-07-16 |
| INTERSTIM THERAPY SYSTEM (P080025/S096) | Medtronic Neuromodulation | 2015-07-16 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S041) | Baxter Healthcare Corp | 2015-07-16 |
| INTERSTIM THERAPY SYSTEM (P080025/S097) | Medtronic Neuromodulation | 2015-07-16 |
| SYNCHROMED INFUSION SYSTEM (P860004/S231) | Medtronic, Inc. | 2015-07-16 |
| FLEXTEND PACING LEADS (P960006/S044) | Boston Scientific | 2015-07-16 |
| CAPSUREFIX MRI LEAD (P090013/S191) | Medtronic, Inc. | 2015-07-16 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| INFUSE BONE GRAFT (P050053/S033) | Medtronic, Inc. | 2015-07-15 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S056) | Medtronic Sofamor Danek USA, Inc. | 2015-07-15 |
| LIPOSORBER LA-15 SYSTEM (P910018/S017) | Kaneka Pharma America Corp. | 2015-07-15 |
| INFUSE BONE GRAFT (P000054/S042) | Medtronic Sofamor Danek USA, Inc. | 2015-07-15 |
| LCS TOTAL KNEE SYSTEM (P830055/S163) | Depuy, Inc. | 2015-07-15 |
| THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO (P850022/S024) | Ahp Eos Buyer, Inc. | 2015-07-15 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S003) | Bard Peripheral Vascular, Inc. | 2015-07-15 |
| MELODY TRANSCATHETER PULMONARY VALVE (P140017/S001) | Medtronic, Inc. | 2015-07-15 |
| CAPSUREFIX MRI LEAD (P090013/S189) | Medtronic, Inc. | 2015-07-14 |
| LCS TOTAL KNEE SYSTEM (P830055/S162) | Depuy, Inc. | 2015-07-14 |
| COREVALVE ENVOLUT R SYSTEM (P130021/S015) | Medtronic, Inc. | 2015-07-14 |
| CAPSUREFIX NOVUS LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACTIVE FIX (P930039/S134) | Medtronic, Inc. | 2015-07-14 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S357) | ABBOTT MEDICAL | 2015-07-13 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S286) | ABBOTT MEDICAL | 2015-07-13 |