| LifeVest Wearable Defibrillator (P010030/S105) | Zoll Manufacturing Corporation | 2018-05-18 |
| Implantable System for Remodulin (P140032/S006) | Medtronic, Inc. | 2018-05-18 |
| Impella 2.5 and Impella CP Ventricular Support System (P140003/S032) | Abiomed, Inc. | 2018-05-18 |
| Watchman Left Atrial Appendage Closure Technology (P130013/S019) | Boston Scientific Corp | 2018-05-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S010) | ABBOTT MEDICAL | 2018-05-18 |
| Optiguide Fiber Optic Diffuser (P940010/S015) | Pinnacle Biologics, Inc. | 2018-05-18 |
| Restylane Lyft with Lidocaine (P040024/S099) | Q-Med AB | 2018-05-18 |
| Alere NMP22 BladderChek Test (P940035/S015) | Abbott Diagnostics Scarborough, Inc. | 2018-05-17 |
| Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S082) | Integra LifeSciences Corporation | 2018-05-17 |
| Aptima HCV Quant Dx Assay (P160023/S003) | Hologic, Inc. | 2018-05-17 |
| NovaSure Impedance Controlled Endometrail Ablation Device (P010013/S070) | Hologic, Inc. | 2018-05-17 |
| Helistat, Helitene Absorbable Collagen Hemostatic Agents (P850010/S081) | Integra LifeSciences Corporation | 2018-05-17 |
| Aptima HBV Quant Assay (P170025/S003) | Hologic, Inc. | 2018-05-17 |
| Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regeneration Matr (P900033/S070) | Integra Lifesciences Corp. | 2018-05-17 |
| Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck (P010054/S034) | Roche Diagnostics Corp. | 2018-05-17 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XR DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S671) | Medtronic Cardiac Rhythm Disease Management | 2018-05-16 |
| Fineline ll Lead Family (P960004/S084) | Boston Scientific | 2018-05-16 |
| Astron Pulsar/Pulsar-18 Stent Systems (P160025/S004) | Biotronik AG | 2018-05-16 |
| Endotak Reliance IS-1 Lead Family, Endotak Reliance IS4 Lead Family, Reliance 4-Front Lead Family (P910073/S149) | Boston Scientific | 2018-05-16 |
| 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/S629) | Medtronic Cardiac Rhythm Disease Management | 2018-05-16 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S370) | Medtronic, Inc. | 2018-05-16 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S066) | Integra Lifesciences Corp. | 2018-05-16 |
| 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/S551) | Medtronic, Inc. | 2018-05-16 |
| Pro-Kinetic Energy Coronary Stent System (P160003/S004) | Biotronik AG | 2018-05-16 |
| Ingevity Lead Family (P150012/S059) | Boston Scientific | 2018-05-16 |
| Revo MRI SureScan IPG (P090013/S283) | Medtronic, Inc. | 2018-05-16 |
| TatiCath Quartz Set (P130026/S032) | St Jude Medical | 2018-05-16 |
| Acuity Spiral Lead Family, Acuity X4 Lead Family (P010012/S483) | Boston Scientific Corp | 2018-05-16 |
| NeuroPace RNS System (P100026/S054) | NeuroPace, Inc. | 2018-05-16 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S006) | Biotronik AG | 2018-05-16 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S035) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S063) | Roche Molecular Systems, Inc. | 2018-05-15 |
| LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level) (P110009/S021) | Highridge Medical, LLC | 2018-05-15 |
| Astron Pulsar/Pulsar-18 Stent System (P140030/S007) | Biotronik AG | 2018-05-15 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S064) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Inspire Upper Airway Stimulator (P130008/S033) | Inspire Medical Systems | 2018-05-15 |
| Cobas HPV Test (P100020/S030) | Roche Molecular Systems, Inc. | 2018-05-15 |
| RONDO 2 Audio Processor & WaterWear for RONDO 2 (P000025/S099) | Med-El Corp. | 2018-05-15 |
| LDR Spine Mobi-C Cervical Disc Prosthesis (One Level) (P110002/S021) | Highridge Medical, LLC | 2018-05-15 |
| COAPTITE Injectable Implant (P040047/S051) | Merz North America, Inc. | 2018-05-15 |
| EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG) (P110042/S107) | Boston Scientific Corporation | 2018-05-15 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S062) | Roche Molecular Systems, Inc. | 2018-05-15 |
| Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D (P060027/S096) | MicroPort CRM USA, Inc. | 2018-05-14 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S090) | Boston Scientific Corp | 2018-05-14 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S122) | MicroPort CRM USA, Inc. | 2018-05-14 |
| Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR (P980049/S131) | MicroPort CRM USA, Inc. | 2018-05-14 |
| Dimension TPSA Flex Reagent Cartridge (P000021/S037) | Siemens Healthcare Diagnostics | 2018-05-14 |
| Dimension FPSA Flex Reagent Cartidge (P020027/S032) | Siemens Healthcare Diagnostics | 2018-05-14 |
| AMS 800 Urinary Control System with and without Inhibizone (P000053/S089) | Boston Scientific Corp | 2018-05-11 |
| Implantable System for Remodulin (P140032/S004) | Medtronic, Inc. | 2018-05-11 |
| Restore, Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stim (P840001/S395) | Medtronic Neuromodulation | 2018-05-11 |
| Nucleus 24 Cochlear Implant System (P970051/S178) | Cochlear Americas | 2018-05-11 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| WaveLight EX500 Laser System (P020050/S029) | Alcon Laboratories, Inc. | 2018-05-11 |
| Restylane Refyne, Restylane Defyne Injectable Gels (P140029/S006) | Q-Med AB | 2018-05-11 |
| Activa Deep Brain Stimulation Therapy System (P960009/S312) | Medtronic, Inc. | 2018-05-11 |
| InterStim Therapy System, Verify Evaluation System (P970004/S269) | Medtronic Neuromodulation | 2018-05-11 |
| InterStim Therapy System, Verify Evaluation System (P080025/S164) | Medtronic Neuromodulation | 2018-05-11 |
| Nucleus 24 Auditory Brainstem Implant (P000015/S032) | Cochlear Americas | 2018-05-11 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S303) | Medtronic, Inc. | 2018-05-11 |
| WaveNet Planning Software (P030008/S025) | Alcon Laboratories, Inc. | 2018-05-11 |
| Inspire Upper Airway Stimulation Therapy (P130008/S029) | Inspire Medical Systems | 2018-05-11 |
| HEMOBLAST Bellows (P170012/S003) | Dilon Technologies, Inc. | 2018-05-10 |
| Tecnis 3-piece Acrylic Monofocal (P990080/S046) | Johnson & Johnson Surgical Vision, Inc. | 2018-05-09 |
| Tecnis 3-piece Multifocal (P080010/S015) | Johnson & Johnson Surgical Vision, Inc. | 2018-05-09 |
| Tecnis CL (P880081/S041) | Johnson & Johnson Surgical Vision, Inc. | 2018-05-09 |
| Atellica IM Hepatitis C (aHCV) (P030056/S011) | Siemens Healthcare Diagnostics | 2018-05-09 |
| Exablate 4000 System (P150038/S007) | Insightec | 2018-05-09 |
| Sensar 1-piece IOL, Tecnis 1-piece IOL, Tecnis 1-piece Optiblue IOL, Preloaded Tecnis 1-piece IOL, Preloaded Tecnis 1-pi (P980040/S088) | Johnson & Johnson Surgical Vision, Inc. | 2018-05-09 |
| Advisa DR IPG, Advisa DDR MRI IPG and Advisa SR MRI IPG (P980035/S547) | Medtronic, Inc. | 2018-05-08 |
| Revo MRI SureScan IPG (P090013/S279) | Medtronic, Inc. | 2018-05-08 |
| Spectranetics Laser Sheaths SLS (SLS ll/GlideLight) (P960042/S060) | Spectranetics (Philips) | 2018-05-08 |
| SYNOJOYNT (P170016) | Mesoblast | 2018-05-08 |
| Consulta, Syncra and Viva CRT-P (P010015/S367) | Medtronic, Inc. | 2018-05-08 |
| S-ICD Battery Anode Laser Edge Weld Process (P110042/S109) | Boston Scientific Corporation | 2018-05-08 |
| CVX-300 Excimer Laser System/ELCA Coronary Atherectomy Catheter (P910001/S104) | Spectranetics Corp. | 2018-05-08 |
| Ovation iX Abdominal Stent Graft System (P120006/S030) | Endologix, LLC | 2018-05-08 |
| Dexcom G4 Platinum Continuous Glucose Monitoring System and Dexcom 5 Mobile Continuous Glucose Monitoring System (P120005/S067) | Dexcom, Inc. | 2018-05-07 |
| GELSYN-3 (P110005/S003) | Ibsa Institut Biochimique SA | 2018-05-07 |
| Edwards Intuity Elite Valve System, Aortic Valve Model 8300AB and Delivery System Model 8300DB (P150036/S029) | Edwards Lifesciences, LLC | 2018-05-07 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve (P150048/S020) | Edwards Lifesciences, LLC | 2018-05-07 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S089) | Edwards Lifesciences, LLC | 2018-05-07 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S053) | Ahp Eos Buyer, Inc. | 2018-05-07 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S064) | Ahp Eos Buyer, Inc. | 2018-05-07 |
| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S065) | Edwards Lifesciences, LLC | 2018-05-07 |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis (P860057/S178) | Edwards Lifesciences, LLC | 2018-05-07 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S063) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Reliance 4- Front Lead Family and Suture Sleeve Accessory (P910073/S145) | Boston Scientific | 2018-05-04 |
| Tridyne Vascular Sealant (P150016/S013) | Neomend, Inc. | 2018-05-04 |
| EBI OsteoGen Impantable Bone Growth Stimulators (P790005/S063) | Ahp Eos Buyer, Inc. | 2018-05-04 |
| Vistakon (Senofilcon A) Brand Contact Lenses (P040045/S097) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-05-04 |
| Evera MRI DF-1 ICD, Evera MRI ICD< Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S669) | Medtronic Cardiac Rhythm Disease Management | 2018-05-04 |
| Cobas HCV (P150015/S014) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Gen V CryoConsole RoHS Compliant (P100010/S076) | Medtronic Cryocath, LP | 2018-05-04 |
| Voluma XC, Vollure XC, Volbella XC (P110033/S039) | Allergan | 2018-05-04 |
| Cobas HBV (P150014/S015) | Roche Molecular Systems, Inc. | 2018-05-04 |
| 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/S627) | Medtronic Cardiac Rhythm Disease Management | 2018-05-04 |
| Cobas CMV (P160041/S008) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Oxford Partial Knee System (P010014/S075) | Biomet Manufacturing Corp | 2018-05-04 |
| Gen V CryoConsole (P020045/S087) | Medtronic Cryocath, LP | 2018-05-04 |