| Freestyle Libre Flash Glucose Monitoring System (P160030/S016) | Abbott Diabetes Care, Inc. | 2018-04-25 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, (P980035/S544) | Medtronic, Inc. | 2018-04-25 |
| Collastat, Absorable Collagen, Hemostatic Sponge Collastat, Absorbable Collagen Hemostatic Agent, Microfibrillar Form (P810006/S081) | Integra LifeSciences Corporation | 2018-04-25 |
| RADIESSE (+) Lidocaine Dermal Filler 1.5CC (P050052/S104) | Merz North America, Inc. | 2018-04-24 |
| ETI-CORE-IGMK PLUS Assay (P990044/S024) | DiaSorin, Inc. | 2018-04-24 |
| ETI-AB-AUK PLUS Assay (P990042/S023) | DiaSorin, Inc. | 2018-04-24 |
| Vercise DBS System (P150031/S003) | Boston Scientific Corp | 2018-04-24 |
| Prostar XL Percutaneous Vascular Surgical System and Perclose ProGlide Suture-Mediated Closure System (P960043/S100) | Abbott Vascular, Inc. | 2018-04-24 |
| ETI-EBK PLUS Assay (P990043/S027) | DiaSorin, Inc. | 2018-04-24 |
| RADIESSE Injectable Implant 1.5CC (P050037/S088) | Merz North America, Inc. | 2018-04-24 |
| ETI-AB-COREK PLUS Assay (P990045/S024) | DiaSorin, Inc. | 2018-04-24 |
| Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxim (P980016/S658) | Medtronic Cardiac Rhythm Disease Management | 2018-04-24 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, EnPulse Ei IPG, EnPulse E2 IPG, Kappa D (P980035/S534) | Medtronic, Inc. | 2018-04-24 |
| VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System (P840064/S068) | Alcon Laboratories | 2018-04-24 |
| ETI-AB-EBK PLUS Assay (P990041/S026) | DiaSorin, Inc. | 2018-04-24 |
| PROVISC Opthalmic Viscoelastic Device (P890047/S053) | Alcon Research, Ltd. | 2018-04-24 |
| Revo MRI SureScan IPG (P090013/S270) | Medtronic, Inc. | 2018-04-24 |
| MyCareLink Monitor (P890003/S385) | Medtronic, Inc. | 2018-04-24 |
| ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays (P990038/S027) | DiaSorin, Inc. | 2018-04-24 |
| StarClose SE Vascular Closure System (P050007/S036) | Abbott Vascular Devices | 2018-04-24 |
| HeartWare Ventricular Assist System (P100047/S119) | Medtronic | 2018-04-24 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S355) | Medtronic, Inc. | 2018-04-24 |
| Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D, (P010031/S618) | Medtronic Cardiac Rhythm Disease Management | 2018-04-24 |
| VenaSeal Closure System (P140018/S011) | Medtronic Vascular, Inc. | 2018-04-24 |
| Micra (P150033/S032) | Medtronic, Inc. | 2018-04-24 |
| Attain Ability and Performa Lead (P080006/S120) | Medtronic, Inc. | 2018-04-23 |
| Attain StarFix Lead (P060039/S086) | Medtronic, Inc. | 2018-04-23 |
| Sprint Quattro Lead (P920015/S211) | Medtronic, Inc. | 2018-04-23 |
| CapSure Sense Lead, CapSure SP Novus Lead, and VItatron Crystalline Lead (P830061/S156) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| LCS Total Knee System (P830055/S196) | Depuy, Inc. | 2018-04-23 |
| CapSureFix MRI Lead (P090013/S277) | Medtronic, Inc. | 2018-04-23 |
| TECNIS Toric1-Piece Intraocular Lenses (IOLs) Models ZCT300 and ZCT400 (P980040/S086) | Johnson & Johnson Surgical Vision, Inc. | 2018-04-23 |
| Bellafill Dermal Filler (P020012/S025) | Tiger Aesthetics Medical, LLC | 2018-04-23 |
| BIOLON (P960011/S030) | Altacor , Ltd. | 2018-04-23 |
| Attain StarFix Lead (P060039/S085) | Medtronic, Inc. | 2018-04-23 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S364) | Medtronic, Inc. | 2018-04-23 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S132) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S155) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S388) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S183) | Medtronic, Inc. | 2018-04-23 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S362) | Medtronic, Inc. | 2018-04-23 |
| Artic Front Advance Cardiac CryoAblation Catheters (P100010/S077) | Medtronic Cryocath, LP | 2018-04-23 |
| CapSure VDD 2 Lead and Vitatron Brilliant S+ VDD Lead (P890003/S389) | Medtronic, Inc. | 2018-04-23 |
| Transvene CS/SVC Lead (P980050/S116) | Medtronic, Inc. | 2018-04-23 |
| Sprint Quattro Lead, Transvene CS/SVC Lead (P920015/S210) | Medtronic, Inc. | 2018-04-23 |
| Transvene CS/SVC Lead (P980050/S115) | Medtronic, Inc. | 2018-04-23 |
| Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVS Lead (P920015/S212) | Medtronic, Inc. | 2018-04-23 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S131) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| CapSureFix MRI Lead (P090013/S274) | Medtronic, Inc. | 2018-04-23 |
| Attain Ability Lead, Attain Performa Lead (P080006/S119) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S185) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix MRI Lead (P090013/S276) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S184) | Medtronic, Inc. | 2018-04-23 |
| Elecsys Anti-HBc IgM (P110031/S022) | Roche Diagnostics Corp. | 2018-04-20 |
| Guardian Connect System (P160007/S002) | Medtronic Minimed | 2018-04-20 |
| Transcend Hip Articulation System (P010001/S018) | Ceramtec GmbH | 2018-04-20 |
| Elecsys Anti-HBs Immunoassay (P010054/S035) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys total PSA (P990056/S031) | Roche Diagnostics Corp. | 2018-04-20 |
| Medtronic MiniMed 670G System (P160017/S041) | Medtronic Minimed, Inc. | 2018-04-20 |
| Elecsys Anbti-HCV Immunoassay (P090007/S019) | Roche Diagnostics Corp. | 2018-04-20 |
| Elecsys Anti-HBc II (P100032/S018) | Roche Diagnostics Corp. | 2018-04-20 |
| TRIDYNE Vascular Sealant (P150016/S012) | Neomend, Inc. | 2018-04-20 |
| Elecsys HBsAg Immunoassay (P990012/S031) | Roche Diagnostics Corp. | 2018-04-20 |
| Activa Deep Brain Stimulation Therapy System (P960009/S311) | Medtronic, Inc. | 2018-04-20 |
| Elecsys Anti-HBc II (P100031/S023) | Roche Diagnostics Corp. | 2018-04-20 |
| MED-EL Cochlear Implants (P000025/S098) | Med-El Corp. | 2018-04-20 |
| Elecsys Anti-HCV II (P140021/S013) | Roche Diagnostics Operations, Inc. | 2018-04-20 |
| Medtronic MiniMed 630G System (P150001/S043) | Medtronic Minimed | 2018-04-20 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S394) | Medtronic Neuromodulation | 2018-04-20 |
| COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S010) | Companion Spine France | 2018-04-20 |
| Elecsys free PSA (P000027/S030) | Roche Diagnostics Corp. | 2018-04-20 |
| Emblem S-ICD Electrode Delivery System (model 4712) (P110042/S102) | Boston Scientific Corporation | 2018-04-19 |
| Superion® Indirect Decompression System (P140004/S013) | Boston Scientific Neuromodulation | 2018-04-19 |
| Biocor Valve, Epic Valve, Epic Supra Valve (P040021/S035) | ABBOTT MEDICAL | 2018-04-19 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S004) | Bard Peripheral Vascular, Inc. | 2018-04-19 |
| Air Optix Aqua, Air Optix Plus HydraGlyde Soft Contact Lenses (P010019/S064) | Alcon Laboratories, Inc. | 2018-04-19 |
| Sprint Quattro Lead (6935M), Sprint Quattro Lead (6935) (P920015/S206) | Medtronic, Inc. | 2018-04-19 |
| ADVIA Centaur HBsAgII (HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control (P110041/S004) | Siemens Corp. | 2018-04-19 |
| Hancock II Porcine Bioprosthesis (P980043/S066) | Medtronic, Inc. | 2018-04-19 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter (P140010/S037) | Medtronic, Inc. | 2018-04-19 |
| Hancock Low Porosity Valved Conduit (P870078/S041) | Medtronic, Inc. | 2018-04-19 |
| Oxford Patrial Knee System (P010014/S073) | Biomet Manufacturing Corp | 2018-04-19 |
| Lead Cap Kit (model 7007) (P910073/S146) | Boston Scientific | 2018-04-19 |
| Mosaic Procine Bioprosthesis (P990064/S075) | Medtronic, Inc. | 2018-04-19 |
| Freestyle Aortic Root Bioprosthesis (P970031/S063) | Medtronic, Inc. | 2018-04-19 |
| Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S033) | ABBOTT MEDICAL | 2018-04-19 |
| Hancock Modified Orifice Valved Conduit (P790007/S056) | Medtronic Heart Valves | 2018-04-19 |
| cobas EGFR Mutation Test v2 (P120019/S018) | Roche | 2018-04-18 |
| ThinPrep Integrated Imager (P950039/S036) | Hologic, Inc. | 2018-04-18 |
| Animas Vibe System (P130007/S035) | Animas Corp. | 2018-04-18 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S086) | Medtronic Vascular | 2018-04-18 |
| cobas EGFR Mutation Test v2 (P120019/S016) | Roche | 2018-04-18 |
| Enroute Transcarotid Stent System (P140026/S009) | Boston Scientific Corporation | 2018-04-18 |
| Freezor Cardiac CryoAblation Catheter, Freezor Xtra Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation (P020045/S086) | Medtronic Cryocath, LP | 2018-04-17 |
| Arctic Front Cardiac CryoAblation Catheter and Arctic Front Advance Cardiac CryoAblation Catheter (P100010/S073) | Medtronic Cryocath, LP | 2018-04-17 |
| t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S024) | Tandem Diabetes Care, Inc. | 2018-04-17 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S025) | Abbott Diabetes Care, Inc. | 2018-04-17 |
| Sensar IOL, Tecnis Toric, Tecnis Symfony, Tecnis Symfony Toric (P980040/S087) | Johnson & Johnson Surgical Vision, Inc. | 2018-04-17 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S013) | Tiger Aesthetics Medical, LLC | 2018-04-17 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S002) | Medinol, Ltd. | 2018-04-17 |