| REBEL Platinum Chromium Coronary Stent System (Monorail and OVer-The-Wire) (P130030/S045) | Boston Scientific Corp | 2017-11-01 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S167) | Boston Scientific Corp | 2017-11-01 |
| NIRTRAKS Clinical Study (P110004/S023) | Medinol, Ltd. | 2017-11-01 |
| FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips (P990009/S050) | Baxter Healthcare Corp | 2017-11-01 |
| Express SD Monorail Premounted Stent System (P060006/S087) | Boston Scientific Corp | 2017-11-01 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (rebrand of PROMUS Element Plus) (P110010/S147) | Boston Scientific Corp | 2017-11-01 |
| enVista Hydrophobic Acrylic Intraocular Lens (P910056/S026) | Bausch & Lomb, Inc. | 2017-11-01 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S098) | Abbott Vascular, Inc. | 2017-11-01 |
| Blazer II Cardiac Ablation System (P920047/S105) | Boston Scientific Corp | 2017-11-01 |
| Impella Ventricular Support System (P140003/S020) | Abiomed, Inc. | 2017-11-01 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019/S001) | Roche Diagnostics, Inc. | 2017-11-01 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S030) | Boston Scientific Corp | 2017-11-01 |
| Physio-Stim (P850007/S037) | Orthofix, Inc. | 2017-10-31 |
| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK) (P840064/S062) | Alcon Laboratories | 2017-10-31 |
| Attesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca (P980035/S522) | Medtronic, Inc. | 2017-10-31 |
| HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% SODIUM HYALURONATE), MODEL VT585 (P110007/S009) | Johnson & Johnson Surgical Vision, Inc. | 2017-10-31 |
| MiniMed 670G System (P160017/S018) | Medtronic Minimed, Inc. | 2017-10-31 |
| MiniMed 630G System with SmartGuard (P150001/S022) | Medtronic Minimed | 2017-10-31 |
| Gore Tag Thoracic Endoprosthesis (P040043/S096) | W. L. Gore & Associates, Inc. | 2017-10-31 |
| PROVISC Ophthalmic Viscosurgical Device (latex-ftee packaging configuration) (P890047/S048) | Alcon Research, Ltd. | 2017-10-31 |
| Precision Montage MRI Spinal Cord Stimulator (SCS) Systems (P030017/S303) | Boston Scientific Corp | 2017-10-31 |
| Precision Montage MRI Spinal Cord Stimulator (SCS) Systems (P030017/S304) | Boston Scientific Corp | 2017-10-31 |
| HEALON DUET DUAL PACK (P810031/S059) | Johnson & Johnson Surgical Vision, Inc. | 2017-10-31 |
| SJM MRI Activator (P140033/S012) | ABBOTT MEDICAL | 2017-10-30 |
| Juvederm Volbella XC (P110033/S031) | Allergan | 2017-10-27 |
| ReZoom 3-Piece Multifocal IOL (P960028/S040) | Johnson & Johnson Surgical Vision, Inc. | 2017-10-27 |
| Animas Vibe System (P130007/S027) | Animas Corp. | 2017-10-27 |
| Tecnis 3-Piece Multifocal IOL (P080010/S014) | Johnson & Johnson Surgical Vision, Inc. | 2017-10-27 |
| BSC Wolverine Coronary Cutting Balloon (P950020/S084) | Boston Scientific Corp | 2017-10-27 |
| EMBLEM S-ICD (P110042/S094) | Boston Scientific Corporation | 2017-10-27 |
| SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, Preloaded TECNIS 1-Piece IOL, TECNIS Multiocal 1-Piece IOL, TECNIS Toric 1-Piece (P980040/S084) | Johnson & Johnson Surgical Vision, Inc. | 2017-10-27 |
| Tecnis 3-Piece Multifocal IOL (P990080/S045) | Johnson & Johnson Surgical Vision, Inc. | 2017-10-27 |
| HiResolution Bionic Ear System - Universal Headpiece (UHP) 2.0 (P960058/S125) | Advanced Bionics | 2017-10-26 |
| Restore, ltrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces and Vectris Spinal Cord Stimulation Lead (P840001/S373) | Medtronic Neuromodulation | 2017-10-26 |
| InterStim Therapy System, Verify Evaluation System (P970004/S252) | Medtronic Neuromodulation | 2017-10-26 |
| Valitude, Valitude X4, Visionist, Visionist X4 - Accolade Cardiac Resynchronization Therapy (P030005/S163) | Guidant Corp. | 2017-10-26 |
| Amplia MRI CRT-D/ Quad CRT_D; Brava CRT-D/ Quad CRT-D; Claria MRI CRT-D / Quad CRT-D; Compia MRI Quad CRT-D; Viva Quad X (P010031/S606) | Medtronic Cardiac Rhythm Disease Management | 2017-10-26 |
| Autogen, Dynagen, Inogen, Origen - NG3 Cardiac Resynchronization Therapy / Momentum, Vigilant, Resonate - NG4 CRT-D Devi (P010012/S466) | Boston Scientific Corp | 2017-10-26 |
| cobas HCV Test (P150015/S009) | Roche Molecular Systems, Inc. | 2017-10-26 |
| ReShape Integrated Dual Balloon System (P140012/S011) | Boston Scientific Corporation | 2017-10-26 |
| Altrua, Essentio, Proponent, Accolade - Accolade Non-MRI Pacemakers (N970003/S215) | Boston Scientific Corp | 2017-10-26 |
| Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD. (P980016/S645) | Medtronic Cardiac Rhythm Disease Management | 2017-10-26 |
| PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (IS1) and 1744 (IS4) (P060027/S088) | MicroPort CRM USA, Inc. | 2017-10-26 |
| Minimed 630G Pump (P150001/S025) | Medtronic Minimed | 2017-10-26 |
| MiniMed 670G System (P160017/S023) | Medtronic Minimed, Inc. | 2017-10-26 |
| InterStim Therapy System, Verify Evaluation System (Bowel) (P080025/S147) | Medtronic Neuromodulation | 2017-10-26 |
| PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (P980049/S123) | MicroPort CRM USA, Inc. | 2017-10-26 |
| Autogen, Dynagen, Inogen,Origen / NG3 Implantable Cardiac Defibrillators / Momentur, Vigilant, Perciva, Resonate / NG4 I (P960040/S407) | Boston Scientific | 2017-10-26 |
| BRACAnalysis CDx Device (P140020/S013) | Myriad Genetic Laboratories | 2017-10-26 |
| Essentio MRI, Proponent MRI, Accolade MRI - Accolade MRI Pacemakers (P150012/S041) | Boston Scientific | 2017-10-26 |
| Angio Seal Vascular Closure Device (P930038/S086) | Terumo Medical Corporation | 2017-10-26 |
| Activa Deep Brain Stimulation Therapy System (P960009/S291) | Medtronic, Inc. | 2017-10-26 |
| cobas HBV Test (P150014/S010) | Roche Molecular Systems, Inc. | 2017-10-26 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator (P090028/S011) | Ortho-Clinical Diagnostics, Inc. | 2017-10-26 |
| OPHTHALMIC VICOSURGICAL DEVICE (OVD) (P840064/S064) | Alcon Laboratories | 2017-10-25 |
| Raindrop Near Vision Inlay (P150034/S004) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2017-10-25 |
| Nucleus 24 Cochlear Implant System (P970051/S171) | Cochlear Americas | 2017-10-25 |
| Collastat Absorbable Collagen Hemostatic Sponge and COLLASTAT Absorbable Collagen Hemostatic Agemt- Microfibrillar Form (P810006/S078) | Integra LifeSciences Corporation | 2017-10-25 |
| Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form (P850010/S077) | Integra LifeSciences Corporation | 2017-10-25 |
| En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, Maximo II DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD /XT ICD, (P980016/S639) | Medtronic Cardiac Rhythm Disease Management | 2017-10-25 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S049) | Alcon Research, Ltd. | 2017-10-25 |
| HiResolution Bionic Ear System (P960058/S124) | Advanced Bionics | 2017-10-25 |
| Concerto ICD, Concerto II CRT-D, Conslta DR4 ICD, Consulta ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Prot (P010031/S600) | Medtronic Cardiac Rhythm Disease Management | 2017-10-25 |
| Seprafilm Adhesion Barrier (P950034/S049) | Baxter Healthcare Corporation | 2017-10-25 |
| CapSure Fix Novus Lead (4076, 5076) (P930039/S176) | Medtronic, Inc. | 2017-10-24 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay System (P090026/S021) | Beckman Coulter, Inc. | 2017-10-24 |
| Navi-Star Diagnostics/ Ablation Deflectable Tip Catheter (P990025/S052) | Biosense Webster, Inc. | 2017-10-24 |
| Access AFP Immunoassay (P980041/S039) | Beckman Coulter, Inc. | 2017-10-24 |
| Safire Bi-Directional Ablation Catheters, Livewire TC Ablation Catheter (P960016/S070) | St Jude Medical | 2017-10-24 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S084) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-10-24 |
| Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems (P970038/S036) | Beckman Coulter, Inc. | 2017-10-24 |
| CardioMEMS HF System (P100045/S026) | ABBOTT MEDICAL | 2017-10-24 |
| Animas Vibe System (P130007/S031) | Animas Corp. | 2017-10-24 |
| CRTP-Quad: Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bi (P010015/S344) | Medtronic, Inc. | 2017-10-24 |
| Webster Diag/ Ablation Deflectable Tip Catheter (P950005/S064) | Biosense Webster, Inc. | 2017-10-24 |
| Access Hybritech PSA Assay (P850048/S048) | Beckman Coulter, Inc. | 2017-10-24 |
| Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028/S001) | NuMED, Inc. | 2017-10-24 |
| Orion: Astra XT DR MIR IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, AZURE S DR MRI IPG, AZURE S SR (P980035/S521) | Medtronic, Inc. | 2017-10-24 |
| Angio Seal Vascular Closure Device (P930038/S085) | Terumo Medical Corporation | 2017-10-24 |
| Biosense Webster Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters (P030031/S080) | Biosense Webster, Inc. | 2017-10-24 |
| Navistar Thermocool Deflectable Diagnostics/Ablation Catheter (P040036/S058) | Biosense Webster, Inc. | 2017-10-24 |
| CapSure Sense Lead (4074, 4574) (P830061/S150) | Medtronic Cardiac Rhythm Disease Management | 2017-10-24 |
| Koning Breast CT, KBCT (P130025/S003) | Koning Corporation | 2017-10-24 |
| Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter (P010068/S053) | Biosense Webster, Inc. | 2017-10-24 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S001) | The Spectranetics Corp. | 2017-10-23 |
| Guardian Sensor (3) (P160017/S021) | Medtronic Minimed, Inc. | 2017-10-23 |
| Roche cobas HPV Test (P100020/S026) | Roche Molecular Systems, Inc. | 2017-10-23 |
| BARD LIFESTENT and LifeStent CLVascular Stent System (P070014/S054) | Bard Peripheral Vascular, Inc. | 2017-10-23 |
| Guardian Sensor (3) (P150001/S024) | Medtronic Minimed | 2017-10-23 |
| Accolade MRI Pacemakers: ESSENTIO MRI, PROPNENT MRI, ACCOLADE MRI (P150012/S042) | Boston Scientific | 2017-10-20 |
| 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 MRI CR (P010031/S605) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+H (P030054/S320) | ABBOTT MEDICAL | 2017-10-20 |
| Lotrafilcon B Soft Contact Lenses for Daily and Extended Wear (P010019/S060) | Alcon Laboratories, Inc. | 2017-10-20 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S008) | Medtronic Vascular | 2017-10-20 |
| Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S216) | Boston Scientific Corp | 2017-10-20 |
| Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P): VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S164) | Guidant Corp. | 2017-10-20 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown (P130005/S018) | Cardiovascular Systems, Inc. | 2017-10-20 |
| Evera MRI ICD/Evera S DR/VR ICD/Evera XT DR/VR ICD/Visia AF MRI VR ICD/Visia AF VR ICD (P980016/S644) | Medtronic Cardiac Rhythm Disease Management | 2017-10-20 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S279) | ABBOTT MEDICAL | 2017-10-20 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic +, Atlas/II/+, Convert/+, Photon (P910023/S382) | ABBOTT MEDICAL | 2017-10-20 |