| Rotablator Rotational Atherectomy System (P900056/S169) | Boston Scientific Corp | 2018-02-16 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S048) | Boston Scientific Corp | 2018-02-16 |
| Express SD Monorail Premounted Stent System (P060006/S090) | Boston Scientific Corp | 2018-02-16 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S097) | Abbott Vascular, Inc. | 2018-02-16 |
| HBeAg Reagent Pack and Calibrator (P090028/S014) | Ortho-Clinical Diagnostics, Inc. | 2018-02-16 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S034) | Boston Scientific Corp | 2018-02-16 |
| Impella RP System (P170011/S003) | Abiomed, Inc. | 2018-02-16 |
| Ceramic Transcend® Hip Articulation System (P030027/S005) | Microport Orthopedics, Inc. | 2018-02-16 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S107) | Boston Scientific Corp | 2018-02-16 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S110) | Boston Scientific | 2018-02-16 |
| Sharps Terminator (P120018/S001) | Sharps Terminator, LLC | 2018-02-16 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S084) | Boston Scientific Corp | 2018-02-16 |
| Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S013) | Ortho-Clinical Diagnostics | 2018-02-16 |
| Stratos LV CRT-P / Stratos LV-T CRT-P / Corox OTW BP Lead / Corox OTW-S BP Lead (P070008/S088) | Biotronik, Inc. | 2018-02-15 |
| Tupoa LV/ATX & Kronos LV-T / CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S114) | Biotronik, Inc. | 2018-02-15 |
| Misago RX Self-expanding Peripheral Stent (P140002/S009) | Terumo Medical Corporation | 2018-02-15 |
| Phylax Implantable Cardioverter Defibrillator System (P980023/S082) | Biotronik, Inc. | 2018-02-15 |
| Karl Storz D-Light C PDD System (P050027/S011) | KARL STORZ Endoscopy-America, Inc. | 2018-02-15 |
| Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing System (P950037/S183) | Biotronik, Inc. | 2018-02-15 |
| Plasmaflo OP-05W(A) (P820033/S012) | Asahi Kasei Medical Co., Ltd. | 2018-02-15 |
| Raindrop Near Vision Inlay (P150034/S007) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-02-15 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S018) | Abbott Diabetes Care, Inc. | 2018-02-15 |
| Paradigm REAL-Time Revel System (P150019/S034) | Medtronic Minimed | 2018-02-14 |
| Paradigm REAL-Time Revel System (P980022/S201) | Medtronic Minimed | 2018-02-14 |
| MiniMed 630G System (P150001/S031) | Medtronic Minimed | 2018-02-14 |
| Nucleus 24 Cochlear Implant System (P970051/S170) | Cochlear Americas | 2018-02-14 |
| ENROUTE Transcarotid Stent System (P140026/S008) | Boston Scientific Corporation | 2018-02-14 |
| Nucleus Auditory Brainstem Implant System (P000015/S026) | Cochlear Americas | 2018-02-14 |
| VNS Therapy System (P970003/S215) | LivaNova USA, Inc. | 2018-02-14 |
| MiniMed 530G System (P120010/S108) | Medtronic, Inc. | 2018-02-14 |
| MiniMed 670G System (P160017/S028) | Medtronic Minimed, Inc. | 2018-02-14 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S023) | Tandem Diabetes Care, Inc. | 2018-02-14 |
| SCS Accessory and A127 Extension Kits (P010032/S137) | ABBOTT MEDICAL | 2018-02-13 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S092) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-02-13 |
| MiniMed 630G System (P150001/S021) | Medtronic Minimed | 2018-02-13 |
| Urinary Control System (P000053/S087) | Boston Scientific Corp | 2018-02-13 |
| Inflatable Penile Prosthesis (N970012/S144) | Boston Scientific Corp | 2018-02-13 |
| PRESTIGE LP Cervical Disc (P090029/S009) | Medtronic Sofamor Danek USA, Inc. | 2018-02-13 |
| MiniMed 670G System (P160017/S017) | Medtronic Minimed, Inc. | 2018-02-13 |
| BD ONCLARITY HPV ASSAY (P160037) | Becton, Dickinson and Company | 2018-02-12 |
| Radiessee Injectable Implant (P050037/S086) | Merz North America, Inc. | 2018-02-12 |
| Micra TPS MC1VR01 (P150033/S030) | Medtronic, Inc. | 2018-02-12 |
| Coaptite (P040047/S049) | Merz North America, Inc. | 2018-02-12 |
| Radiesse Lidocaine Dermal Filler (P050052/S102) | Merz North America, Inc. | 2018-02-12 |
| Gel-One (P080020/S028) | Seikagaku Corp. | 2018-02-09 |
| Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form (P850010/S079) | Integra LifeSciences Corporation | 2018-02-09 |
| BSC Intella Nav MIFI OI Ablation Cathetrs (P150005/S033) | Boston Scientific Corp | 2018-02-09 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S093) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-02-09 |
| IntellaNav St Cardiac Ablation Catheter (P920047/S104) | Boston Scientific Corp | 2018-02-09 |
| STAR Excimer Laser System (P930016/S054) | Amo Manufacturing USA, LLC | 2018-02-09 |
| Collastat Absorable Collagen Hemostatic Sponge and Collastat Absorable Collagen Hemostatic Agent Microfibrillar Form (P810006/S080) | Integra LifeSciences Corporation | 2018-02-09 |
| Diamond Back 360 Coronary Orbital Atherectomy System (P130005/S019) | Cardiovascular Systems, Inc. | 2018-02-09 |
| Elecsys Anti-HBc II, PreciControl Anti-HBc (P100031/S020) | Roche Diagnostics Corp. | 2018-02-09 |
| SUPARTZ FX and VISCO-3 (P980044/S042) | Seikagaku Corp. | 2018-02-09 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S616) | Medtronic Cardiac Rhythm Disease Management | 2018-02-08 |
| VALITUDE CRT-P; VALITUDE X4 CRT-P; VISIONIST (P030005/S173) | Guidant Corp. | 2018-02-08 |
| FINELINE II Lead Family (P960004/S082) | Boston Scientific | 2018-02-08 |
| EMBLEM S-ICD; EMBLEM MRI S-ICD (P110042/S103) | Boston Scientific Corporation | 2018-02-08 |
| digene Hybird Capture 2 (HC2) HPV DNA Test (P890064/S036) | Qiagen Gaithersburg, Inc. | 2018-02-08 |
| ESSENTIO; PROPONENT; ACCOLADE MRI (P150012/S053) | Boston Scientific | 2018-02-08 |
| DYNAGEN X4; INOGEN X4; ORIGEN X4; AUTOGEN X4; MOMENTUM X4; VIGILIANT X4; RESONATE X4/HF; PUNCTUA; ENERGEN; INCEPTA CRT-D (P010012/S478) | Boston Scientific Corp | 2018-02-08 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S001) | Medinol, Ltd. | 2018-02-08 |
| DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM (P960040/S419) | Boston Scientific | 2018-02-08 |
| Isoflex Low Voltage Lead (P960030/S055) | ABBOTT MEDICAL | 2018-02-08 |
| Flextome Coronary Cutting Balloon (P950020/S088) | Boston Scientific Corp | 2018-02-08 |
| Perceval Sutureless Heart Valve (P150011/S011) | Corcym S.r.l. | 2018-02-08 |
| AngioJet Ultra Thrombectomy System Console (P980037/S068) | Boston Scientific Corp | 2018-02-08 |
| CollaCote, Colla Tape, CollaPlug, Absorable Collagen Wound Dressing for Dental Surgery (P840062/S064) | Integra Lifesciences Corp. | 2018-02-08 |
| Hercep Test (P980018/S024) | Agilent Technologies Singapore (International) Pte , Ltd. | 2018-02-08 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC (P980016/S656) | Medtronic Cardiac Rhythm Disease Management | 2018-02-08 |
| ACCOLADE; PROPONENT; ESSENTIO; ALTRUA 2 PACEMAKER (N970003/S225) | Boston Scientific Corp | 2018-02-08 |
| Impella 2.5 & Impella CP Systems (P140003/S027) | Abiomed, Inc. | 2018-02-08 |
| Quickflex u and Quartet CRT Leads (P030054/S346) | ABBOTT MEDICAL | 2018-02-08 |
| Tendril and Optisense f Low Voltage Leads (P960013/S094) | ABBOTT MEDICAL | 2018-02-08 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S001) | Fujirebio Europe N.V. | 2018-02-08 |
| AngioJet Ultra Console (P980037/S069) | Boston Scientific Corp | 2018-02-08 |
| Durata and Optisure High Voltage Leads (P950022/S114) | ABBOTT MEDICAL | 2018-02-08 |
| LifeVest Wearable Defibrillator (P010030/S098) | Zoll Manufacturing Corporation | 2018-02-07 |
| Impella Ventricular Support Systems (P140003/S018) | Abiomed, Inc. | 2018-02-07 |
| Coseal Surgical Sealant (P030039/S021) | Baxter Bio Science | 2018-02-07 |
| InterStim® Sacral Nerve Stimulation Therapy System / Bowel Control (P080025/S148) | Medtronic Neuromodulation | 2018-02-07 |
| ZOLL X Series (P160022/S001) | ZOLL Medical Corporation | 2018-02-07 |
| Closer Vascular Sealing System (P150022/S004) | Rex Medical, L.P. | 2018-02-07 |
| InterStim® Sacral Nerve Stimulation Therapy System (Urinary Control ) (P970004/S253) | Medtronic Neuromodulation | 2018-02-07 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S021) | Lutonix | 2018-02-06 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S017) | Bolton Medical, Inc. | 2018-02-06 |
| AIR OPTIX plus HydraGlyde / AIR OPTIX plus HydraGlyde for Astigmatism / AIR OPTIX plus HydraGlyde Multifocal / AIR OPTIX (P010019/S062) | Alcon Laboratories, Inc. | 2018-02-06 |
| Freezor Cardiac Cryoablation Catheter (4-mm tip), Freezor Xtra Surgical Cardiac Cryoablation Device (6-mm tip), Freezor (P020045/S085) | Medtronic Cryocath, LP | 2018-02-06 |
| InterStim Therapy System, Verify Evaluation System; SNM Bowel Leads (P080025/S156) | Medtronic Neuromodulation | 2018-02-06 |
| Onyx Liquid Embolic System (P030004/S014) | Ev3 Neurovascular | 2018-02-06 |
| InterStim Therapy System, Verify Evaluation System; SNM Urinary Leads (P970004/S261) | Medtronic Neuromodulation | 2018-02-06 |
| Fortify Assura (P910023/S401) | ABBOTT MEDICAL | 2018-02-06 |
| Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S345) | ABBOTT MEDICAL | 2018-02-06 |
| Freezor MAX (P100010/S072) | Medtronic Cryocath, LP | 2018-02-06 |
| Glaukos iStent Trabecular Micro-Bypass Stent System (P080030/S020) | Glaukos Corporation | 2018-02-06 |
| Progel Pleural Air Leak Sealant (P010047/S055) | Neomend, Inc. | 2018-02-05 |
| Precision Novi Spinal Cord Stimulator (SCS) System Flash Memory Component Update (P030017/S307) | Boston Scientific Corp | 2018-02-05 |
| Tridyne Vascular Sealant (P150016/S011) | Neomend, Inc. | 2018-02-05 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S173) | Edwards Lifesciences, LLC | 2018-02-03 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S084) | Edwards Lifesciences, LLC | 2018-02-03 |