| GORE CARDIOFORM Septal Occluder; (P050006/S054) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004/S229) | Medtronic Neuromodulation | 2016-10-24 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S051) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D (P980016/S602) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S150) | Cochlear Americas | 2016-10-21 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S003) | Ventana Medical Systems, Inc. | 2016-10-21 |
| Reocor S, Reocor D (P950037/S168) | Biotronik, Inc. | 2016-10-21 |
| AMS 800 URINARY CONTROL SYSTEM & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT (P000053/S068) | Boston Scientific Corp | 2016-10-21 |
| VENASEAL CLOSURE SYSTEM (P140018/S004) | Medtronic Vascular, Inc. | 2016-10-21 |
| Oxford Partial Knee System (P010014/S056) | Biomet Manufacturing Corp | 2016-10-21 |
| NUCLEUS AUDITORY BRAINSTEM IMPLANT (P000015/S015) | Cochlear Americas | 2016-10-21 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S023) | Medtronic, Inc. | 2016-10-20 |
| IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT (P120011/S007) | Bimini Health Tech | 2016-10-20 |
| VISTAKON SENOFILCON A BRAND CONTACT LENSES (P040045/S059) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-10-20 |
| NATRELLE SALINE FILLED BREAST IMPLANTS (P990074/S034) | Allergan | 2016-10-20 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per (P860057/S152) | Edwards Lifesciences, LLC | 2016-10-20 |
| SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO (P090022/S025) | Lenstec, Inc. | 2016-10-20 |
| IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034/S017) | Samsara Vision, Inc. | 2016-10-20 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S044) | Neomend, Inc. | 2016-10-20 |
| LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL (P100049/S018) | Torax Medical | 2016-10-20 |
| DIMENSION VISTA TPSA ASSAY (P000021/S028) | Siemens Healthcare Diagnostics | 2016-10-19 |
| CARDIOMEMS HF SYSTEM (P100045/S011) | ABBOTT MEDICAL | 2016-10-19 |
| MINIMED 530G INSULIN PUMP (P120010/S095) | Medtronic, Inc. | 2016-10-19 |
| HANCOCK VALVED CONDUIT (P870078/S033) | Medtronic, Inc. | 2016-10-19 |
| cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2 (P120019/S012) | Roche | 2016-10-19 |
| COBAS KRAS MUTATION TEST (P140023/S008) | Roche Molecular Systems, Inc. | 2016-10-19 |
| Cobas EGFR MUTATION TEST v2 (P150047/S002) | Roche Molecular Systems, Inc. | 2016-10-19 |
| Paradigm REAL-Time Revel Insulin Pump (P980022/S195) | Medtronic Minimed | 2016-10-19 |
| Paradigm REAL-Time Insulin Pump (P150019/S020) | Medtronic Minimed | 2016-10-19 |
| DIMENSION VISTA FPSA ASSAY (P020027/S023) | Siemens Healthcare Diagnostics | 2016-10-19 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S055) | Roche Molecular Systems, Inc. | 2016-10-18 |
| ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY (P090024/S001) | Siemens Healthcare Diagnostics | 2016-10-18 |
| VENTANA PD-L1 (SP142) Assay (P160006) | Ventana Medical Systems, Inc. | 2016-10-18 |
| CONSULTA/SYNCRA/VIVA CRT-Ps (P010015/S311) | Medtronic, Inc. | 2016-10-18 |
| COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit (P050028/S054) | Roche Molecular Systems, Inc. | 2016-10-18 |
| ADAPTA/VERSA/SENSIA/ADVISA DR/ADVISA DR MRI/ADVISA SR MRI/RELIA IPGs (P980035/S477) | Medtronic, Inc. | 2016-10-18 |
| MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRTUOSO II DR/VR ICDs (P980016/S604) | Medtronic Cardiac Rhythm Disease Management | 2016-10-18 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT (P140002/S004) | Terumo Medical Corporation | 2016-10-18 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S115) | ABBOTT MEDICAL | 2016-10-18 |
| PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM; MRI SPINAL CORD STIMULATOR (SCS) SYSTEM. (P030017/S255) | Boston Scientific Corp | 2016-10-18 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT CRT-Ds (P010031/S565) | Medtronic Cardiac Rhythm Disease Management | 2016-10-18 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT (P140002/S003) | Terumo Medical Corporation | 2016-10-18 |
| Epi proColon (P130001/S002) | New Day Diagnostics, LLC | 2016-10-18 |
| COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S029) | Roche Molecular Systems, Inc. | 2016-10-18 |
| COBAS HPV TEST (P100020/S021) | Roche Molecular Systems, Inc. | 2016-10-18 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030) | Smith & Nephew, Inc. | 2016-10-17 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S185) | Medtronic, Inc. | 2016-10-17 |
| MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S142) | Medtronic Cardiac Rhythm Disease Management | 2016-10-17 |
| CapSureFix Novus Lead 4076, 5076 (P930039/S160) | Medtronic, Inc. | 2016-10-16 |
| CapSureFix MRI Lead 5086MRI (P090013/S236) | Medtronic, Inc. | 2016-10-16 |
| MISAGO RX Self-expanding Peripheral Stent (P140002/S005) | Terumo Medical Corporation | 2016-10-14 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL (MR) (P150003/S021) | Boston Scientific Corporation | 2016-10-14 |
| SJM BIOCOR AND EPIC VALVES (P040021/S027) | ABBOTT MEDICAL | 2016-10-14 |
| LUTONIX DRUG COATED BALLOON PTA CATETER (P130024/S015) | Lutonix | 2016-10-14 |
| LIPOSORBER(R) LA-15 SYSTEM (P910018/S021) | Kaneka Pharma America Corp. | 2016-10-14 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S134) | Boston Scientific Corp | 2016-10-14 |
| INSPIRE II IMPLANTABLE PULSE GENERATOR (P130008/S015) | Inspire Medical Systems | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S052) | W. L. Gore & Associates, Inc. | 2016-10-13 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S014) | Bolton Medical, Inc. | 2016-10-13 |
| LifeVest Wearable Defibrillator (P010030/S083) | Zoll Manufacturing Corporation | 2016-10-13 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S088) | Spectranetics Corp. | 2016-10-13 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DYNAGEN, INOGEN, ORIGEN, X4 CRT-D: (P010012/S434) | Boston Scientific Corp | 2016-10-13 |
| Paradigm REAL-Time Revel Insulin Pump with Enlite Sensor System (P150019/S022) | Medtronic Minimed | 2016-10-13 |
| IMPLANTABLE CARDIOVETER DEFIBRILLATOR, DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA MINI, EL, ICD (P960040/S382) | Boston Scientific | 2016-10-13 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR DEVICE (S-ICD) SYSTEM EMBLEM (P110042/S065) | Boston Scientific Corporation | 2016-10-13 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S057) | Biomet Manufacturing Corp | 2016-10-13 |
| CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574. (P830061/S129) | Medtronic Cardiac Rhythm Disease Management | 2016-10-12 |
| WALLSTENT ENDOPROSTHESIS LLIAC (P940019/S048) | Boston Scientific Scimed, Inc. | 2016-10-12 |
| INVIVE, INTUA, INGENIO 2, VALITUDE, VALITUDE X4 CRT-P (P030005/S143) | Guidant Corp. | 2016-10-12 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S225) | Medtronic, Inc. | 2016-10-12 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S046) | Syncardia Systems, LLC | 2016-10-12 |
| DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 NG3 CRT-D; INCEPTA, ENERGEN, PUNCTUA PROGENY CRT-D (P010012/S433) | Boston Scientific Corp | 2016-10-12 |
| EVERA MRI XT DR SURESCAN MODEL DDMB1D1, EVERA MRI XT VR SURESCAN MODEL DVMB1D1, EVERA MRI S DR SURESCAN MODEL DDMC3D1, E (P980016/S586) | Medtronic Cardiac Rhythm Disease Management | 2016-10-12 |
| ESSENTIO, PROPONENT, ACCOLADE PACEMAKER (P150012/S016) | Boston Scientific | 2016-10-12 |
| INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG) (N970003/S195) | Boston Scientific Corp | 2016-10-12 |
| ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO (P960040/S381) | Boston Scientific | 2016-10-12 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S057) | Boston Scientific Corp | 2016-10-12 |
| VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S058) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-10-12 |
| AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0 (P930014/S092) | Alcon Laboratories, Inc. | 2016-10-12 |
| WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S046) | Boston Scientific Corporation | 2016-10-12 |
| LCS TOTAL KNEE SYSTEM (P830055/S173) | Depuy, Inc. | 2016-10-12 |
| EMBLEM AND EMBLEM MRI S-ICD SYSTEM (P110042/S064) | Boston Scientific Corporation | 2016-10-12 |
| CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK (P890003/S354) | Medtronic, Inc. | 2016-10-12 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 (P930039/S151) | Medtronic, Inc. | 2016-10-12 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935 (DF-1), SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947 (DF-1) (P920015/S178) | Medtronic, Inc. | 2016-10-12 |
| URO VYSION BLADDER CANCER KIT (P030052/S019) | Abbott Molecular | 2016-10-11 |
| Rotablator Rotational Atherectomy System (P900056/S155) | Boston Scientific Corp | 2016-10-11 |
| BIOFINITY XR TORIC (P080011/S048) | CooperVision, Inc. | 2016-10-11 |
| Superion® Interspinous Spacer (P140004/S004) | Boston Scientific Neuromodulation | 2016-10-11 |
| BIOFINITY XR TORIC (P080011/S047) | CooperVision, Inc. | 2016-10-11 |
| VYSIS ALK BREAK APART FISH PROBE KIT. (P110012/S012) | Abbott Molecular, Inc. | 2016-10-11 |
| ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR (P070009/S017) | Obtech Medical GmbH | 2016-10-11 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR (P100001/S009) | Ortho-Clinical Diagnostics | 2016-10-10 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S005) | Abbott Vascular, Inc. | 2016-10-07 |
| NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S017) | Allergan | 2016-10-07 |
| KAMRA INLAY (P120023/S002) | Corneagen | 2016-10-07 |
| HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% Sodium Hyaluronate) (P110007/S008) | Johnson & Johnson Surgical Vision, Inc. | 2016-10-07 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S035) | Allergan | 2016-10-07 |
| HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S070) | Integra LifeSciences Corporation | 2016-10-07 |