| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S445) | Medtronic, Inc. | 2015-11-25 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM (P120002/S009) | Cordis US Corporation | 2015-11-25 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT XT CRT-D (P010031/S519) | Medtronic Cardiac Rhythm Disease Management | 2015-11-25 |
| ELECSYS ANTI-HBC-IGM (P110025/S012) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S022) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HCV (P090008/S015) | Roche Diagnostics Corp. | 2015-11-24 |
| SYNCHROMED II PROGRAMMABLE INFUSION PUMP (P860004/S224) | Medtronic, Inc. | 2015-11-24 |
| ELECSYS ANTI-HBC (P100032/S010) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HCV (P090009/S013) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HCV II (P140021/S001) | Roche Diagnostics Operations, Inc. | 2015-11-24 |
| ELECSYS ANTI-HBC-IGM (P110031/S011) | Roche Diagnostics Corp. | 2015-11-24 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S008) | Lutonix | 2015-11-24 |
| ELECSYS FREE PSA IMMUNOASSAY (P000027/S021) | Roche Diagnostics Corp. | 2015-11-24 |
| COSEAL SURGICAL SEALANT, COSEAL REPLACEMENT APPLICATOR, COSEAL EXTENDED APPLICATOR (P030039/S019) | Baxter Bio Science | 2015-11-24 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S024) | Corcym Canada Corp | 2015-11-24 |
| ELECSYS ANTI-HBS (P010054/S025) | Roche Diagnostics Corp. | 2015-11-24 |
| APTIMA HPV ASSAY (P100042/S007) | Gen-Probe Incorporated | 2015-11-24 |
| PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S240) | Boston Scientific Corp | 2015-11-24 |
| PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN (P130018) | Uromedica, Inc. | 2015-11-24 |
| ELECSYS HBEAG (P130015/S004) | Roche Diagnostics Operations, Inc. | 2015-11-24 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC (AUI) STENT GRAFT SYSTEM (P100021/S050) | Medtronic Vascular | 2015-11-24 |
| PROMETRA PROGRAMMABLE IMPLANTABLE PUMP (P080012/S032) | Infusyn Therapeutics, LLC | 2015-11-24 |
| ELECSYS ANTI-HBC-IGM (P110022/S014) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HBC (P100031/S013) | Roche Diagnostics Corp. | 2015-11-24 |
| ELECSYS ANTI-HCV (P090007/S013) | Roche Diagnostics Corp. | 2015-11-24 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S116) | Advanced Bionics | 2015-11-24 |
| ELECSYS HBSAG (P990012/S023) | Roche Diagnostics Corp. | 2015-11-24 |
| PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S146) | Medtronic Minimed | 2015-11-23 |
| MINIMED 530G INSULIN PUMP (P120010/S004) | Medtronic, Inc. | 2015-11-23 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S011) | Medtronic, Inc. | 2015-11-23 |
| RESTYLANE (P040024/S089) | Q-Med AB | 2015-11-23 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S045) | Coloplast Corp. | 2015-11-23 |
| RADIESSE INJECTABLE IMPLANT (P050052/S069) | Merz North America, Inc. | 2015-11-23 |
| RESTYLANE-L (P040024/S088) | Q-Med AB | 2015-11-23 |
| BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) (P100025/S009) | Meridian Bioscience, Inc. | 2015-11-23 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S042) | Zimmer, Inc. | 2015-11-23 |
| LUTONIX DRUG COATED BALLOON (P130024/S003) | Lutonix | 2015-11-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR (P000044/S033) | Ortho-Clinical Diagnostics, Inc. | 2015-11-20 |
| SALINE-FILLED & SPECTRUM BREAST IMPLANTS (P990075/S034) | Mentor Worldwide, LLC | 2015-11-20 |
| SYNCHROMED INFUSION SYSTEM (P860004/S242) | Medtronic, Inc. | 2015-11-20 |
| MEMORYSHAPE BREAST IMPLANTS (P060028/S015) | Mentor Worldwide, LLC | 2015-11-20 |
| MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS (P030053/S032) | Mentor Corp. | 2015-11-20 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S241) | Medtronic, Inc. | 2015-11-20 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY & VECTRIS SPINAL CORD STIMULATION (P840001/S316) | Medtronic Neuromodulation | 2015-11-20 |
| INTERSTIM THERAPY SYSTEM (P080025/S102) | Medtronic Neuromodulation | 2015-11-20 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S067) | Medtronic | 2015-11-20 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S136) | Cochlear Americas | 2015-11-20 |
| VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER (P970003/S186) | LivaNova USA, Inc. | 2015-11-20 |
| INTERSTIM THERAPY SYSTEM (P970004/S207) | Medtronic Neuromodulation | 2015-11-20 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S005) | Lutonix | 2015-11-20 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028) | Nuvectra Corporation | 2015-11-20 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S053) | Biomet Manufacturing Corp | 2015-11-20 |
| ENVISTA HYDROPHOBIC INTRAOCULAR LENS (P910056/S019) | Bausch & Lomb, Inc. | 2015-11-19 |
| DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D, ORIGEN CRT-D & X4 CRT-D (P010012/S403) | Boston Scientific Corp | 2015-11-19 |
| EMBLEM S-ICD SYSTEM (P110042/S055) | Boston Scientific Corporation | 2015-11-19 |
| TACTICATH QUARTZ SET (P130026/S009) | St Jude Medical | 2015-11-19 |
| ORIGEN EL, INOGEN EL, DYNAGEN EL ICD'S ; ORIGEN MINI, INOGEN MINI, DYNAGEN MINI ICD'S (P960040/S358) | Boston Scientific | 2015-11-19 |
| INGENIO 2 CRT-P, VALITUDE & VALTITUDE X4 CRT-PS (P030005/S130) | Guidant Corp. | 2015-11-19 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S086) | Alcon Laboratories, Inc. | 2015-11-19 |
| COCHLEAR C1500 SERIES IMPLANTS (P970051/S131) | Cochlear Americas | 2015-11-19 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S183) | Boston Scientific Corp | 2015-11-19 |
| SYNCHROMED INFUSION SYSTEM (P860004/S241) | Medtronic, Inc. | 2015-11-19 |
| SPRINT QUATTRO LEAD (P920015/S167) | Medtronic, Inc. | 2015-11-18 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S239) | Boston Scientific Corp | 2015-11-18 |
| BRACANALYSIS CDX (P140020/S003) | Myriad Genetic Laboratories | 2015-11-18 |
| SELECTSECURE LEAD (P030036/S080) | Medtronic Cardiac Rhythm Disease Management | 2015-11-18 |
| SUPERION INTERSPINOUS SPACER (P140004/S001) | Boston Scientific Neuromodulation | 2015-11-18 |
| MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER (P100009/S010) | ABBOTT MEDICAL | 2015-11-18 |
| CAPSUREFIX LEAD (P930039/S143) | Medtronic, Inc. | 2015-11-18 |
| AFX ENDOVASCULAR AAA STENT SYSTEM (P040002/S056) | Endologix, LLC | 2015-11-18 |
| CAPSUREFIX MRI LEAD (P090013/S208) | Medtronic, Inc. | 2015-11-18 |
| ENLITE SENSOR (P120010/S073) | Medtronic, Inc. | 2015-11-18 |
| PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S238) | Boston Scientific Corp | 2015-11-18 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S010) | Bolton Medical, Inc. | 2015-11-18 |
| VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL) (P030016/S028) | STAAR Surgical Company | 2015-11-17 |
| VISTAKON (SENOFILCON.A) BRAND CONTACT LENSES (P040045/S052) | Vistakon, Division of Johnson & Johnson Vision Car | 2015-11-17 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S058) | St Jude Medical | 2015-11-17 |
| MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE (P960009/S229) | Medtronic, Inc. | 2015-11-17 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S005) | Boston Scientific Corporation | 2015-11-16 |
| COBAS EGFR MUTATION TEST V2 (P120019/S007) | Roche | 2015-11-13 |
| CAPSULAR TENSION RING AND STABILEYES (P030023/S004) | Ophtec BV | 2015-11-13 |
| IMPELLA 2.5 SYSTEM (P140003/S001) | Abiomed, Inc. | 2015-11-13 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S240) | Medtronic, Inc. | 2015-11-12 |
| FREEZOR CARDIAC CRYOBLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC CR (P020045/S068) | Medtronic Cryocath, LP | 2015-11-12 |
| COAPTITE (P040047/S040) | Merz North America, Inc. | 2015-11-12 |
| FREQUENCY XCEL TORIC XR (P850079/S069) | CooperVision, Inc. | 2015-11-12 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S444) | Medtronic, Inc. | 2015-11-12 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S041) | Zimmer, Inc. | 2015-11-12 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D, PROTECTA XT CRT-D, (P010031/S518) | Medtronic Cardiac Rhythm Disease Management | 2015-11-12 |
| LCS TOTAL KNEE SYSTEM (P830055/S164) | Depuy, Inc. | 2015-11-12 |
| RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI (P840001/S315) | Medtronic Neuromodulation | 2015-11-12 |
| GAMBRO PRISMAFLEX TPE 2000 SET (P830063/S008) | Vantive US Healthcare, LLC | 2015-11-12 |
| ENLITE SENSOR (P120010/S029) | Medtronic, Inc. | 2015-11-12 |
| RADIESSE (P050037/S059) | Merz North America, Inc. | 2015-11-12 |
| PROGENSA PCA3 ASSAY (P100033/S004) | Gen-Probe Incorporated | 2015-11-12 |
| FREEZOR MAX CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT ADVANCE CARDIAC CRYOBL (P100010/S051) | Medtronic Cryocath, LP | 2015-11-12 |
| COCHLEAR CI500 SERIES IMPLANTS (P970051/S135) | Cochlear Americas | 2015-11-12 |
| SOF-SENSOR (P980022/S159) | Medtronic Minimed | 2015-11-12 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XI ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S557) | Medtronic Cardiac Rhythm Disease Management | 2015-11-12 |
| PRECISION,PRECISION SPECTRA, PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S234) | Boston Scientific Corp | 2015-11-12 |