| digene HC2 High Risk HPV DNA Test (P890064/S034) | Qiagen Gaithersburg, Inc. | 2017-07-25 |
| Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs (P960040/S396) | Boston Scientific | 2017-07-25 |
| PROPEL AND PROPEL MINI SINUS IMPLANT (P100044/S022) | Intersect Ent. | 2017-07-25 |
| Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A (P010012/S454) | Boston Scientific Corp | 2017-07-25 |
| BOND Oracle HER2 IHC System (P090015/S005) | Leica Biosystems | 2017-07-25 |
| Express® SD Monorail® Premounted Stent System (P060006/S083) | Boston Scientific Corp | 2017-07-24 |
| Blazer (II, II HTD, Primie HTD) (P920047/S098) | Boston Scientific Corp | 2017-07-24 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S022) | Boston Scientific Corp | 2017-07-24 |
| DBS Extensions (P140009/S025) | ABBOTT MEDICAL | 2017-07-24 |
| ACTUITY X4 QUADRIPOLAR CORONARY VENOUS PACE/SENSE LEADS (P010012/S443) | Boston Scientific Corp | 2017-07-24 |
| Chilli II TM Cooled Ablation Catheter and Cable (P980003/S076) | Boston Scientific Corp | 2017-07-24 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S103) | Boston Scientific | 2017-07-24 |
| Blazer (II XP, Prime XP); IntellaTip MiFi XP; IntellaNav XP and IntellaNav MiFi XP (P020025/S101) | Boston Scientific | 2017-07-24 |
| Therascreen EGFR, RGQ, PCR Kit (P120022/S015) | QIAGEN GmbH | 2017-07-24 |
| REBEL TM Platinum Chromium Coronary Stent System (P130030/S041) | Boston Scientific Corp | 2017-07-24 |
| Chilli Cooled RF Ablation System (P980003/S074) | Boston Scientific Corp | 2017-07-24 |
| Blazer IITM Cardiac Ablation Catheter and Cable (P920047/S099) | Boston Scientific Corp | 2017-07-24 |
| PROMUS Element Plus Everolimus-Eiuting Stent System I, PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary (P110010/S142) | Boston Scientific Corp | 2017-07-24 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI (P150005/S020) | Boston Scientific Corp | 2017-07-24 |
| Rotablator® Rotational Atherectomy System (P900056/S162) | Boston Scientific Corp | 2017-07-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S049) | DePuy Orthopaedics, Inc. | 2017-07-24 |
| Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie (P010032/S125) | ABBOTT MEDICAL | 2017-07-21 |
| Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin (P010032/S130) | ABBOTT MEDICAL | 2017-07-21 |
| Therakos CELLEX Photopheresis System (P860003/S090) | Therakos Development Limited | 2017-07-21 |
| ProMRI ICD/CRT-D System (P050023/S110) | Biotronik, Inc. | 2017-07-21 |
| Prometra Programmable Infusion Pump System (P080012/S042) | Infusyn Therapeutics, LLC | 2017-07-21 |
| Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products (P810031/S062) | Johnson & Johnson Surgical Vision, Inc. | 2017-07-20 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S046) | Edwards Lifesciences, LLC | 2017-07-20 |
| EDWARDS INTUITY ELITE Valve System (P150036/S014) | Edwards Lifesciences, LLC | 2017-07-20 |
| EDWARDS SAPIEN XT Transcatheter Heart Valve (P130009/S079) | Edwards Lifesciences, LLC | 2017-07-20 |
| Carpentier-Edwards PERIMOUNT RSR Theon/Magna/Plus Pericardial Aortic Bioprosthesis with ThermalFix tissue process, (P860057/S165) | Edwards Lifesciences, LLC | 2017-07-20 |
| Visian Implantable Collamer Lens for Myopia (P030016/S032) | STAAR Surgical Company | 2017-07-20 |
| Precision Montage (MRI) Spinal COrd Stimulation (SCS) System (P030017/S299) | Boston Scientific Corp | 2017-07-19 |
| OBALON BALLOON SYSTEM (P160001/S001) | Medtimo, Inc. | 2017-07-19 |
| Resolute Onyx RX and OTW Coronary Stent Systems (P160043/S003) | Medtronic Vascular | 2017-07-19 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S001) | Bard Peripheral Vascular, Inc. | 2017-07-19 |
| Flair Endovascular Stent Graft (P060002/S039) | Bard Peripheral Vascular | 2017-07-19 |
| CapSure SP Novus Lead/ CapSure SP Z Lead/ CapSure Z Novus Lead/ Vitatron Impulse II Lead (P850089/S125) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| CapSureFix MRI Lead (P090013/S260) | Medtronic, Inc. | 2017-07-18 |
| Amplia MRI/Quad, Brava/Quad CRT-D, Claria MRI/Quad CRT-D, Compia MRI/Quad CRT-D, Consulta CRT-D, Maximo II CRT-D, Vivad (P010031/S598) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| Attain StarFix Lead (P060039/S079) | Medtronic, Inc. | 2017-07-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S045) | Edwards Lifesciences, LLC | 2017-07-18 |
| CapSure VDD 2 Lead/ Vitron Brilliant S+VDD Lead (P890003/S375) | Medtronic, Inc. | 2017-07-18 |
| Micra TPS (P150033/S025) | Medtronic, Inc. | 2017-07-18 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S005) | Boston Scientific Corporation | 2017-07-18 |
| SLS / GlideLight (P960042/S058) | Spectranetics (Philips) | 2017-07-18 |
| Attain Ability Lead; Attain Performa Lead (P080006/S110) | Medtronic, Inc. | 2017-07-18 |
| Sprint Quattro Lead/ Subcutanious Lead/ Transvene CS.SVC Lead (P920015/S199) | Medtronic, Inc. | 2017-07-18 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S068) | Hologic, Inc. | 2017-07-18 |
| KAMRA INLAY (P120023/S005) | Corneagen | 2017-07-18 |
| ELCA (P910001/S094) | Spectranetics Corp. | 2017-07-18 |
| Adapta, Versa, Sensia IPG, Advisa DR,MRI,SR IPG, Astra S DR, S SR, XT DR, XT SR IPG, Relia IPG (P980035/S511) | Medtronic, Inc. | 2017-07-18 |
| Evera/MRI/DF, ICD, S DR, XT DR, S VR, XT VR, Maximo II ICD, Secura DR ICD/ DR, Visia AF MRI DFI ICD/VR ICD (P980016/S637) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S620) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S579) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| Carpentier-Edwards® PERIMOUNT® Pericardial/RSR/Magna/Magna Ease Aortic/ Plus/ Theon Pericardial Mitral Bioprosthesis wit (P860057/S164) | Edwards Lifesciences, LLC | 2017-07-18 |
| CapSure Sense Lead/ CapSure SP Novus Lead/Vitatron Crystalline Lead (P830061/S147) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| CapSureFix Lead/ CapSureFix Novus Lead/ Vitatron Crystalline Active Fixation Lead (P930039/S173) | Medtronic, Inc. | 2017-07-18 |
| Revo MRI SureScan IPG (P090013/S261) | Medtronic, Inc. | 2017-07-18 |
| Consulta, Percept Bipolar, Percepta Quadripolar, Serena Bipolar/Quadripolar, Syncra, Viva CRT-P (P010015/S336) | Medtronic, Inc. | 2017-07-18 |
| Attain Bipolar OTW Lead; Attain OTW LV Lead (P010015/S335) | Medtronic, Inc. | 2017-07-18 |
| Transvene CS/SVC Lead (P980050/S111) | Medtronic, Inc. | 2017-07-18 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S078) | Edwards Lifesciences, LLC | 2017-07-18 |
| EDWARDS INTUITY Valve System (P150036/S013) | Edwards Lifesciences, LLC | 2017-07-18 |
| AcrySof® IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System (P930014/S102) | Alcon Laboratories, Inc. | 2017-07-18 |
| Dimension FPSA Flex reagent cartridge (RF451) (P020027/S027) | Siemens Healthcare Diagnostics | 2017-07-17 |
| WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CELSIUS CATHETER;; CELSIUS RMT CATHETER (P950005/S063) | Biosense Webster, Inc. | 2017-07-17 |
| Aspire Assist (P150024/S006) | Aspire Bariatrics, Inc. | 2017-07-17 |
| NAVISTAR RMT; NAVISTAR RMT DS CATHETER (P990025/S051) | Biosense Webster, Inc. | 2017-07-17 |
| Dimension TPSA Flex reagent cartridge (RF451) (P000021/S032) | Siemens Healthcare Diagnostics | 2017-07-17 |
| Nucleus Cochlear Implant System (P970051/S161) | Cochlear Americas | 2017-07-17 |
| Medtronic CoreValve System/ Evolut R System/ Evolut PRO System (P130021/S039) | Medtronic, Inc. | 2017-07-17 |
| Star S4 IR Excimer Laser System (P930016/S051) | Amo Manufacturing USA, LLC | 2017-07-14 |
| Supera Peripheral Stent System (P120020/S016) | Abbott Vascular (Idef Technologies Inc) | 2017-07-14 |
| Impella Ventricular Support Systems (P140003/S021) | Abiomed, Inc. | 2017-07-14 |
| Ceramax Ceramic Total Hip System (P070026/S048) | DePuy Orthopaedics, Inc. | 2017-07-13 |
| VenaSeal Closure System (P140018/S007) | Medtronic Vascular, Inc. | 2017-07-13 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S048) | Best Vascular, Inc. | 2017-07-13 |
| AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S126) | Boston Scientific Corp | 2017-07-13 |
| TRYTON Side Branch Stent (P150039/S001) | Poseidon Medical, Inc. | 2017-07-13 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S077) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-07-12 |
| Adapta, Versa Sensia IPG Relia IPG (P980035/S510) | Medtronic, Inc. | 2017-07-12 |
| Combi 40+ Cochlear Implant System (P000025/S096) | Med-El Corp. | 2017-07-12 |
| Vistakon (etafilcon A) Brand Contact Lenses (N18033/S093) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-07-12 |
| Precision Spectra / Novi / Wavewriter Spinal Cord Stimulator (SCS) System, Precision Montage Spinal Cord Stimulator (SCS (P030017/S298) | Boston Scientific Corp | 2017-07-12 |
| Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S010) | Abbott Diabetes Care, Inc. | 2017-07-12 |
| Intellis(TM) Implantable Neurostimulation System (P840001/S344) | Medtronic Neuromodulation | 2017-07-11 |
| Excluder AAA Endoprosthesis (P020004/S145) | W. L. Gore & Associates, Inc. | 2017-07-11 |
| PMMA Posterior Chamber Intraocular Lenses (P840039/S062) | Bausch & Lomb, Inc. | 2017-07-11 |
| Integre Dermal Regeneration Template (P900033/S062) | Integra Lifesciences Corp. | 2017-07-11 |
| CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System (P130021/S033) | Medtronic, Inc. | 2017-07-10 |
| Access Hybritech PSA Reagents on the Access Immunoassy Systems (P850048/S046) | Beckman Coulter, Inc. | 2017-07-07 |
| InterStim Therapy System (Bowel) (P080025/S141) | Medtronic Neuromodulation | 2017-07-07 |
| Spectranetics CVX-300 Exclimer Laser System (P910001/S091) | Spectranetics Corp. | 2017-07-07 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S019) | Beckman Coulter, Inc. | 2017-07-07 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S034) | Beckman Coulter, Inc. | 2017-07-07 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S280) | Medtronic, Inc. | 2017-07-07 |
| InterStim Therapy System (Urinary) (P970004/S246) | Medtronic Neuromodulation | 2017-07-07 |
| Access AFP Reagents on the Access Immunoassy Systems (P980041/S037) | Beckman Coulter, Inc. | 2017-07-07 |
| Oxford Partial Knee System (P010014/S063) | Biomet Manufacturing Corp | 2017-07-07 |