| Stent Graft Drying Process at Medtronic Empalme And Medtronic Tijuana Endurant, Endurant II, Endurant II Aorto-Uni-lliac (P100021/S064) | Medtronic Vascular | 2017-05-19 |
| Activa Deep Brain Stimulation Therapy System (P960009/S278) | Medtronic, Inc. | 2017-05-19 |
| PreveLeak Surgical Sealant & 10pk applictor tips (P100030/S005) | Baxter Healthcare Corporation | 2017-05-19 |
| Livewire TC Ablation Catheter and Safire Bi-Directional Ablation Catheter (P960016/S068) | St Jude Medical | 2017-05-19 |
| THERASCREEN EGFR RGQ PCR KIT (P120022/S014) | QIAGEN GmbH | 2017-05-19 |
| Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter (P040014/S032) | Irvine Biomedical, Inc. | 2017-05-19 |
| C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses (P060011/S011) | Rayner Intraocular Lenses , Ltd. | 2017-05-18 |
| Cardiac Resynchronization Therapy Defibrillator; Dynagen, Inogen, Origen, Autogen CRT-D's (P010012/S446) | Boston Scientific Corp | 2017-05-18 |
| ABBOTT REALTIME CMV (P160044) | Abbott Molecular | 2017-05-18 |
| Implantable Cardioverter Defibrilllator/ Dynagen, Inogen, Origen and Autogen ICD's. (P960040/S390) | Boston Scientific | 2017-05-18 |
| Ophthalmic Viscosurgical Devices (P840064/S066) | Alcon Laboratories | 2017-05-18 |
| PROVISC OVD (P890047/S051) | Alcon Research, Ltd. | 2017-05-18 |
| HiRESOLUTION BIONIC EAR SYSTEM (P960058/S120) | Advanced Bionics | 2017-05-17 |
| COLOGUARD (P130017/S016) | Exact Sciences Corporation | 2017-05-17 |
| Titan Inflatable Penile Prosthesis (P000006/S046) | Coloplast Corp. | 2017-05-17 |
| InterStim Therapy System (Urinary) (P970004/S244) | Medtronic Neuromodulation | 2017-05-16 |
| Therakos Uvar XTS Photopheresis System Procedural Kit. (P860003/S089) | Therakos Development Limited | 2017-05-16 |
| PD-L1 IHC 28-8 pharmDx (P150025/S006) | Agilent Technologies, Inc. | 2017-05-16 |
| EGFR pharmDx (P030044/S003) | Agilent Technologies, Inc. | 2017-05-16 |
| InterStim Therapy System (Bowel) (P080025/S139) | Medtronic Neuromodulation | 2017-05-16 |
| C-Kit pharmDx (P040011/S003) | Dako North America, Inc. | 2017-05-16 |
| Medtronic CoreValve(TM) Evolut (TM) R System (P130021/S031) | Medtronic, Inc. | 2017-05-16 |
| KAMRA INLAY (P120023/S004) | Corneagen | 2017-05-16 |
| Oxford Partial Knee System- Meniscal bearings (P010014/S062) | Biomet Manufacturing Corp | 2017-05-16 |
| PD-L1 IHC 22C3 pharmDx (P150013/S005) | Agilent Technologies, Inc. | 2017-05-16 |
| Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta, Viva Quad MRI CRT-D (P010031/S592) | Medtronic Cardiac Rhythm Disease Management | 2017-05-15 |
| CyPass System (P150037/S005) | Alcon Research, Ltd. | 2017-05-15 |
| MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S005) | Axora Medical, Inc. | 2017-05-15 |
| Evera, Maximo, Protecta, Secura, Visia MRI VR/XT/DR/AF ICD (P980016/S631) | Medtronic Cardiac Rhythm Disease Management | 2017-05-15 |
| Express SD Monorail® Premounted Stent System (P060006/S082) | Boston Scientific Corp | 2017-05-12 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S019) | Boston Scientific Corp | 2017-05-12 |
| PROMUS Element Plus Everolimus-Eiuting Stent System (P110010/S141) | Boston Scientific Corp | 2017-05-12 |
| PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S273) | Boston Scientific Corp | 2017-05-12 |
| Juvederm Voluma® XC and Juvederm Volbella® XC (P110033/S026) | Allergan | 2017-05-12 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S089) | Medtronic | 2017-05-12 |
| Algovita Spinal Cord Stimulation System (P130028/S014) | Nuvectra Corporation | 2017-05-12 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S039) | Boston Scientific Corp | 2017-05-12 |
| Juvederm® Hyaluronate Gel Implants (P050047/S056) | Allergan | 2017-05-12 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S073) | Boston Scientific Corp | 2017-05-12 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S100) | Boston Scientific | 2017-05-12 |
| Blazer II TM Cardiac Ablation Catheter and Cable (P920047/S097) | Boston Scientific Corp | 2017-05-12 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S054) | Syncardia Systems, LLC | 2017-05-12 |
| Rotablator® Rotational Atherectomy System (P900056/S160) | Boston Scientific Corp | 2017-05-12 |
| OraQuick HCV Rapid Antibody Test (P080027/S027) | OraSure Technologies, Inc. | 2017-05-11 |
| Floseal Hemostatie Matrix (P990009/S046) | Baxter Healthcare Corp | 2017-05-11 |
| Activa Deep Brain Stimulation Therapy System (P960009/S277) | Medtronic, Inc. | 2017-05-11 |
| Spectra WaveWriter Spinal Cord Stimulator System (P030017/S290) | Boston Scientific Corp | 2017-05-11 |
| Restore and Itrel Spinal Cord Stimulation Systems (P840001/S358) | Medtronic Neuromodulation | 2017-05-11 |
| TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM (P990040/S024) | Cerenovus, Inc. | 2017-05-11 |
| SYNVISC ONE (P940015/S040) | Sanofi Genzyme Corp. | 2017-05-11 |
| MITRACLIP NT CLIP DELIVER SYSTEM (P100009/S021) | ABBOTT MEDICAL | 2017-05-11 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S063) | Dexcom, Inc. | 2017-05-10 |
| Paradigm Real-Time Insulin Pump & Paradign Real-Time Revel Insulin Pump (P980022/S199) | Medtronic Minimed | 2017-05-10 |
| Epic Vascular Self-Expanding Stent System (P110035/S039) | Boston Scientific Corp | 2017-05-10 |
| COBAS TaqMan HCV Test v2.0, For Use With High Pure System (P060030/S056) | Roche Molecular Systems, Inc. | 2017-05-10 |
| Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath (P960042/S057) | Spectranetics (Philips) | 2017-05-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S038) | Edwards Lifesciences, LLC | 2017-05-10 |
| Express SD Renal Stent System (P060006/S081) | Boston Scientific Corp | 2017-05-10 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S140) | Boston Scientific Corp | 2017-05-10 |
| Rebel Platinum Chromium Coronary Stent System Monorail and Over The Wire (P130030/S038) | Boston Scientific Corp | 2017-05-10 |
| EDWARDS INTUITY Valve System (P150036/S007) | Edwards Lifesciences, LLC | 2017-05-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S073) | Edwards Lifesciences, LLC | 2017-05-10 |
| Wolverine Coronary Cutting Balloon (P950020/S080) | Boston Scientific Corp | 2017-05-10 |
| MiniMed 530G Insulin Pump (P120010/S103) | Medtronic, Inc. | 2017-05-10 |
| MiniMed 630G Insulin Pump (P150001/S014) | Medtronic Minimed | 2017-05-10 |
| Paradigm REAL-Time Revel Insulin Pump (P150019/S029) | Medtronic Minimed | 2017-05-10 |
| COBAS TaqMan HBV Test, For Use With High Pure System (P050028/S055) | Roche Molecular Systems, Inc. | 2017-05-10 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S289) | Boston Scientific Corp | 2017-05-10 |
| MiniMed 670G Pump (P160017/S012) | Medtronic Minimed, Inc. | 2017-05-10 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis (P860057/S159) | Edwards Lifesciences, LLC | 2017-05-10 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S029) | Boston Scientific Corporation | 2017-05-10 |
| Nucleus Hybrid Cochlear Implant System (P130016/S025) | Cochlear Americas | 2017-05-09 |
| Nucleus 24 Cochlear Implant System (P970051/S160) | Cochlear Americas | 2017-05-09 |
| Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System (P150023/S008) | Abbott Vascular, Inc. | 2017-05-09 |
| Medtronic CoreValve System (P130021/S034) | Medtronic, Inc. | 2017-05-09 |
| Nucleus AB1541 Auditory Brainstem Implant (P000015/S020) | Cochlear Americas | 2017-05-09 |
| QUANTTFERON-TB Gold (P010033/S033) | Qiagen | 2017-05-09 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S019) | Mentor Worldwide, LLC | 2017-05-08 |
| Precision Montage MRI and Precision Montage Spinal Cord Stimulator (SCS)Systems (P030017/S281) | Boston Scientific Corp | 2017-05-08 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S031) | Medtronic, Inc. | 2017-05-08 |
| IntellaNav Ol (P150005/S015) | Boston Scientific Corp | 2017-05-08 |
| IntellaNav XP, Nav MiFi XP (P020025/S096) | Boston Scientific | 2017-05-08 |
| MEMORYGEl BREAST IMPLANTS (P030053/S036) | Mentor Corp. | 2017-05-08 |
| AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment (N970012/S131) | Boston Scientific Corp | 2017-05-08 |
| Pacemaker ICD CRT Non Implanted components. (P000009/S071) | Biotronik, Inc. | 2017-05-06 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD (P930039/S166) | Medtronic, Inc. | 2017-05-06 |
| Edora / Enitra /Enticos / Evity PSW 1701.U (P950037/S175) | Biotronik, Inc. | 2017-05-06 |
| PERCEPTA QUAD CRT-P MRI SURESCAN, SERENA QUAD CRT-P MRI SURESCAN, SOLARA QUAD CRT-P MRI SURESCAN, IMPLANTABLE PULSE GENE (P010015/S317) | Medtronic, Inc. | 2017-05-06 |
| SELECTSECURE LEAD MODEL 3830 (P030036/S091) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization (P050023/S107) | Biotronik, Inc. | 2017-05-06 |
| Eluna / Epyra / Etrinsa (P070008/S082) | Biotronik, Inc. | 2017-05-06 |
| MODEL 6725 IS-1 PIN PLUG (P920015/S191) | Medtronic, Inc. | 2017-05-06 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD (P930039/S165) | Medtronic, Inc. | 2017-05-06 |
| Lumos DR-T/VR-T (P000009/S072) | Biotronik, Inc. | 2017-05-06 |
| CAPSURE SENSE MRI SURESCAN LEAD (P830061/S141) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| SELECTSECURE MRI SURESCAN LEAD (P030036/S092) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S244) | Medtronic, Inc. | 2017-05-06 |
| ASTRA XT SR MRI SURESCAN, ASTRA XT DR MRI SURESCAN, ASTRA S SR MRI SURESCAN, ASTRA S DR MRI SURESCAN, SOFTWARE MODEL (P980035/S486) | Medtronic, Inc. | 2017-05-06 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S245) | Medtronic, Inc. | 2017-05-06 |
| Inventra / Iperia / Itrevia (P050023/S108) | Biotronik, Inc. | 2017-05-06 |