| Superion Indirect Decompression System (P140004/S012) | Boston Scientific Neuromodulation | 2018-03-26 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v.20 (P060030/S062) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas TaqMan HBV Test, Cobas AmpliPep/Cobas, TaqMan HBV Test, v2.0, Cobas AmpliPrep (P050028/S061) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas HBV Test (P150014/S014) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas HCV Test (P150015/S013) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva (P960040/S418) | Boston Scientific | 2018-03-26 |
| Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI (P150012/S052) | Boston Scientific | 2018-03-26 |
| Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent (N970003/S224) | Boston Scientific Corp | 2018-03-26 |
| SYNERGY Everolimus-Eluting Platinum Chronium Coronary Stent System (P150003/S032) | Boston Scientific Corporation | 2018-03-23 |
| Obalon Balloon System (P160001/S013) | Medtimo, Inc. | 2018-03-23 |
| Selenia Dimensions/3Dimensions 3D System (P080003/S006) | Hologic, Inc. | 2018-03-23 |
| Gore Cardioform Septal Occluder (P050006/S063) | W. L. Gore & Associates, Inc. | 2018-03-23 |
| MiniMed 630G System (P150001/S040) | Medtronic Minimed | 2018-03-22 |
| Essure System for Permanent Birth Control (P020014/S050) | Bayer Pharma AG | 2018-03-22 |
| Excluder AAA Endoprosthesis (P020004/S151) | W. L. Gore & Associates, Inc. | 2018-03-22 |
| Coseal Surgical Sealant Spray Set (P030039/S022) | Baxter Bio Science | 2018-03-22 |
| Coseal Surgical Sealant (P030039/S020) | Baxter Bio Science | 2018-03-22 |
| Impella CP System (P140003/S026) | Abiomed, Inc. | 2018-03-22 |
| ProCol Vascular Bioprosthesis (P020049/S005) | LeMaitre Vascular, Inc. | 2018-03-22 |
| MiniMed 670G System (P160017/S038) | Medtronic Minimed, Inc. | 2018-03-22 |
| RSONATE, MOMENTUM and VIGILANT NG4 CRT-DS (P010012/S480) | Boston Scientific Corp | 2018-03-22 |
| Organ Care System (OCS) Lung System (P160013) | TransMedics, Inc. | 2018-03-22 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S050) | ABBOTT MEDICAL | 2018-03-22 |
| RESONATE, MOMENTUM, VIGILANT, and PERCIVA NG4 ICDs (P960040/S421) | Boston Scientific | 2018-03-22 |
| QuickFlex u, Quartet (P030054/S350) | ABBOTT MEDICAL | 2018-03-21 |
| Gore Tag Thoracic Endoprosthesis (P040043/S098) | W. L. Gore & Associates, Inc. | 2018-03-21 |
| Bellafill Dermal Filler (P020012/S019) | Tiger Aesthetics Medical, LLC | 2018-03-21 |
| DuraSeal Exact Spine Sealant System (P080013/S015) | Integra LifeSciences Corporation | 2018-03-21 |
| IsoFlex (P960030/S058) | ABBOTT MEDICAL | 2018-03-21 |
| DuraSeal Dural Sealant System (P040034/S027) | Integra LifeSciences Corporation | 2018-03-21 |
| Tendril SDX, OptiSense, Tendril STS, Tendril ST (P960013/S097) | ABBOTT MEDICAL | 2018-03-21 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S014) | Nevro Corporation | 2018-03-21 |
| Attesta DR MRI SueScan, Attesta L DR MRI SureScan, Attesta S DR MRI SureScan, Attesta SR MRI SureScan, Sphera DR MRI Sur (P980035/S537) | Medtronic, Inc. | 2018-03-21 |
| Durata, Optisure (P950022/S118) | ABBOTT MEDICAL | 2018-03-21 |
| Gore Excluder AAA Endoprosthesis (P020004/S150) | W. L. Gore & Associates, Inc. | 2018-03-21 |
| OptiSense; Tendril STS, Tendril SDX, Tendril ST (P960013/S096) | ABBOTT MEDICAL | 2018-03-20 |
| S.M.A.R.T. Control Nitinol Stent System (P020036/S038) | Cordis US Corporation | 2018-03-20 |
| Platinium CRT-D 1741; Platinium 4LV CRT-D 1744 (P060027/S094) | MicroPort CRM USA, Inc. | 2018-03-20 |
| 6996T Tunneling Tool Sterile Barrier System (P920015/S208) | Medtronic, Inc. | 2018-03-20 |
| S.M.A.R.T. and S.M.A.R.T. Control Vascular Stent Systems (P120002/S013) | Cordis US Corporation | 2018-03-20 |
| Tendril (P140033/S027) | ABBOTT MEDICAL | 2018-03-20 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S039) | Smith & Nephew, Inc. | 2018-03-20 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S012) | Abbott Diabetes Care, Inc. | 2018-03-20 |
| Platinium VR 1240; Platinium DR 1540 (P980049/S129) | MicroPort CRM USA, Inc. | 2018-03-20 |
| QuickFlex, Quartet (P030054/S349) | ABBOTT MEDICAL | 2018-03-20 |
| IsoFlex (P960030/S057) | ABBOTT MEDICAL | 2018-03-20 |
| Durata, Optisure (P950022/S117) | ABBOTT MEDICAL | 2018-03-20 |
| Epi proColon (P130001/S004) | New Day Diagnostics, LLC | 2018-03-20 |
| Precise Nitinol Stent Systems (P030047/S035) | Cordis US Corporation | 2018-03-20 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S017) | Nevro Corporation | 2018-03-19 |
| ROTAPRO Advancer; ROTAPRO; ROTAPRO Console (P900056/S166) | Boston Scientific Corp | 2018-03-19 |
| WATCHMAN Left Atrial Appendage CLosure (LAAC) Device with Delivery System (P130013/S018) | Boston Scientific Corp | 2018-03-19 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead (P830061/S154) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| Nucleus Hybrid Cochlear Implant System (P130016/S034) | Cochlear Americas | 2018-03-16 |
| digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S039) | Qiagen Gaithersburg, Inc. | 2018-03-16 |
| End Cap and Upsizing Sleeve (P900061/S148) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S009) | Edwards Lifesciences, LLC | 2018-03-16 |
| CapSure VDD 2 Lead, Servuce Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S387) | Medtronic, Inc. | 2018-03-16 |
| Cobas CMV (P160041/S006) | Roche Molecular Systems, Inc. | 2018-03-16 |
| Transvene CS/SVC Lead (P980050/S114) | Medtronic, Inc. | 2018-03-16 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM (P030011/S060) | Syncardia Systems, LLC | 2018-03-16 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S099) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| Nucleus 24 Cochlear Implant System (P970051/S177) | Cochlear Americas | 2018-03-16 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead (P930039/S180) | Medtronic, Inc. | 2018-03-16 |
| RF Marinr, Unipolar Mapping RF Marinr, RF Conductr MC, RF Enhancr, and RF Contactr (P930029/S059) | Medtronic, Inc. | 2018-03-16 |
| Nucleus AB1541 Auditory Brainstem Implant (P000015/S031) | Cochlear Americas | 2018-03-16 |
| Myocardial Pacing Lead (P120017/S012) | Medtronic, Inc. | 2018-03-16 |
| Attain Ability Lead and Attain Performa Lead (P080006/S118) | Medtronic, Inc. | 2018-03-16 |
| CapSure Epicardial Pacing Lead (P950024/S078) | Medtronic, Inc. | 2018-03-16 |
| Attain StarFix Lead (P060039/S084) | Medtronic, Inc. | 2018-03-16 |
| Wolverine Coronary Cutting Balloon Monorail (MR) and Over-the-Wire (OTW) (P950020/S089) | Boston Scientific Corp | 2018-03-16 |
| DF-1 Connector Port Pin Plug, IS-1 COnnector Port Pin Plug Kit, Springt Quattro Lead, Subcutaneous Lead, and Transvene C (P920015/S207) | Medtronic, Inc. | 2018-03-16 |
| CapSure SP and Z Novus Lead, Vitatron Excellence SS+ Lead and Vitatron Impulse II Lead (P850089/S130) | Medtronic Cardiac Rhythm Disease Management | 2018-03-16 |
| Resolute Onyx Coronary Stent System (P160043/S011) | Medtronic Vascular | 2018-03-15 |
| GEL-ONE (P080020/S026) | Seikagaku Corp. | 2018-03-15 |
| HeartWare Ventricular Assist System (P100047/S111) | Medtronic | 2018-03-15 |
| Linx Reflux Management System (P100049/S021) | Torax Medical | 2018-03-15 |
| Arctic Front Advance Cardiac CryoAblation Catheter (P100010/S075) | Medtronic Cryocath, LP | 2018-03-15 |
| SUPARTZ FX and VISCO-3 (P980044/S039) | Seikagaku Corp. | 2018-03-15 |
| Pacemakers Reply SR/DR and Esprit SR/DR (P950029/S120) | MicroPort CRM USA, Inc. | 2018-03-15 |
| HeartWare HVAD System (P100047/S114) | Medtronic | 2018-03-15 |
| BVI 1% OVD (formerly BD 1% OVD and Biolon) (P960011/S029) | Altacor , Ltd. | 2018-03-15 |
| Resolute Integrity Coronary Stent Systems (P110013/S087) | Medtronic Vascular | 2018-03-15 |
| Attain StarFix Model 4195 Lead (P060039/S083) | Medtronic, Inc. | 2018-03-15 |
| ETI-AB-EBK PLUS Assay (P990041/S024) | DiaSorin, Inc. | 2018-03-14 |
| HiResolution Bionic Ear System (P960058/S128) | Advanced Bionics | 2018-03-14 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S095) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-03-14 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S058) | Ahp Eos Buyer, Inc. | 2018-03-14 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S097) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2018-03-14 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S046) | Ahp Eos Buyer, Inc. | 2018-03-14 |
| ETI-AB-AUK PLUS Assay (P990042/S021) | DiaSorin, Inc. | 2018-03-14 |
| Supartz FX and Visco-3 (P980044/S043) | Seikagaku Corp. | 2018-03-14 |
| ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays (P990038/S025) | DiaSorin, Inc. | 2018-03-14 |
| ETI-EBK PLUS Assay (P990043/S025) | DiaSorin, Inc. | 2018-03-14 |
| ETI-CORE-IGMK PLUS Assay (P990044/S022) | DiaSorin, Inc. | 2018-03-14 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S057) | Ahp Eos Buyer, Inc. | 2018-03-14 |
| Legacy MDT Pocket Adapter (P140009/S034) | ABBOTT MEDICAL | 2018-03-14 |
| Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S078) | CooperVision, Inc. | 2018-03-14 |
| Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S071) | CooperVision, Inc. | 2018-03-14 |
| Gel-One (P080020/S029) | Seikagaku Corp. | 2018-03-14 |