| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S036) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Juvederm Ultra, Ultra XC, Ultra Plus, Ultra Plus XC (P050047/S065) | Allergan | 2018-05-04 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S052) | Ahp Eos Buyer, Inc. | 2018-05-04 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S064) | Roche Molecular Systems, Inc. | 2018-05-04 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S070) | Medtronic Cryocath, LP | 2018-05-04 |
| Progel Pleural Air Leak Sealant (P010047/S056) | Neomend, Inc. | 2018-05-04 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S008) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
| Talent Occluder (P100021/S071) | Medtronic Vascular | 2018-05-03 |
| Atellica IM Hepatitis B core Antigen (aHBcM) (P030040/S012) | Siemens Healthcare Diagnostics | 2018-05-03 |
| 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/S625) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S169) | ABBOTT MEDICAL | 2018-05-03 |
| Advisa DR IPG, Advisa DR/SR MRI IPG, Astra XT DR MRI IPG, Astra S DR/SR/XT MRI IPG, Azure S DR/SR MRI IPG, Azure XT DR/S (P980035/S548) | Medtronic, Inc. | 2018-05-03 |
| Endurant, Endurant II, Endurant IIs (P100021/S070) | Medtronic Vascular | 2018-05-03 |
| Evera NRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S667) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S366) | Medtronic, Inc. | 2018-05-03 |
| Assurity, Assurity +, Endurity (P880086/S298) | ABBOTT MEDICAL | 2018-05-03 |
| Endurity MRI, Assurity MRI (P140033/S029) | ABBOTT MEDICAL | 2018-05-03 |
| Revo MRI SureScan IPG (P090013/S280) | Medtronic, Inc. | 2018-05-03 |
| Micra TPS (P150033/S035) | Medtronic, Inc. | 2018-05-03 |
| Valiant Captivia (P100040/S035) | Medtronic Vascular | 2018-05-03 |
| Elecsys Total PSA, Total PSA CalSet ll (P990056/S032) | Roche Diagnostics Corp. | 2018-05-03 |
| Amplia MR CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT_D, Claria MRI Quad CRT-D, Compia M (P010031/S623) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S665) | Medtronic Cardiac Rhythm Disease Management | 2018-05-03 |
| Ceramic Total Hip System (P070026/S053) | DePuy Orthopaedics, Inc. | 2018-05-02 |
| Heart Light Catheter with Excalibur Balloon (P150026/S002) | Cardiofocus, Inc. | 2018-05-02 |
| LCS Total Knee System (P830055/S199) | Depuy, Inc. | 2018-05-02 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S365) | Medtronic, Inc. | 2018-05-02 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra (P980035/S546) | Medtronic, Inc. | 2018-05-02 |
| t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System (P140015/S025) | Tandem Diabetes Care, Inc. | 2018-05-02 |
| VisuMax Femtosecond Laser System (P150040/S002) | Carl Zeiss Meditec, Inc. | 2018-05-02 |
| Impella CP with SmartAssist (P140003/S030) | Abiomed, Inc. | 2018-05-02 |
| 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/S624) | Medtronic Cardiac Rhythm Disease Management | 2018-05-02 |
| Micra TPS (P150033/S034) | Medtronic, Inc. | 2018-05-02 |
| SynCardia temporary Total Artificial Heart (TAH-t) (P030011/S051) | Syncardia Systems, LLC | 2018-05-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S666) | Medtronic Cardiac Rhythm Disease Management | 2018-05-02 |
| Revo MRI SureScan IPG (P090013/S278) | Medtronic, Inc. | 2018-05-02 |
| Ceramax Ceramic Total Hip System (P070026/S054) | DePuy Orthopaedics, Inc. | 2018-05-02 |
| HEMOBLAST Bellows (P170012/S001) | Dilon Technologies, Inc. | 2018-05-02 |
| Juvederm Voluma XC, Vollure XC, and Juvederm Volbella XC (P110033/S038) | Allergan | 2018-05-01 |
| SCULPTRA Aesthetic (injectable poly-L Lactic acid) (P030050/S028) | Q-Med AB | 2018-05-01 |
| Minerva Endometrial Ablation System (P140013/S009) | Axora Medical, Inc. | 2018-05-01 |
| MiSeqDx Praxis Extended RAS Panel (P160038/S003) | Illumina, Inc. | 2018-05-01 |
| Juvederm Ultra, Ultra XC, Ultra Plus, and Juvederm Ultra Plus XC (P050047/S064) | Allergan | 2018-05-01 |
| Misago RX Self-expanding Peripheral Stent (P140002/S012) | Terumo Medical Corporation | 2018-04-30 |
| Bausch + Lomb Ultra (samfilcon A) Contact Lenses (P170035) | Bausch and Lomb, Inc., | 2018-04-30 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S545) | Medtronic, Inc. | 2018-04-30 |
| Impella 2.5 System, Impella CP System, Impella CP Optical System, Impella 5.0 System, and Impella LD System (P140003/S029) | Abiomed, Inc. | 2018-04-30 |
| Impella RP System (P170011/S005) | Abiomed, Inc. | 2018-04-30 |
| Obalon Balloon System (P160001/S014) | Medtimo, Inc. | 2018-04-28 |
| LifePulse High Frequency Ventilator (P850064/S036) | Bunnell, Inc. | 2018-04-27 |
| MEDTRONIC DBS THERAPY FOR EPILEPSY (P960009/S219) | Medtronic, Inc. | 2018-04-27 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S302) | Medtronic, Inc. | 2018-04-27 |
| MynxGrip, Mynx Ace Vascular Closure Device (VCD) (P040044/S080) | Cordis US Corporation | 2018-04-27 |
| Acrysof IQ Aspheric UV absorbing IOL with the UltraSert Pre-Loaded Delivery System (P930014/S110) | Alcon Laboratories, Inc. | 2018-04-26 |
| Angio-Seal Vascular Closure Devices (P930038/S088) | Terumo Medical Corporation | 2018-04-26 |
| Euflexxa (1% Sodium Hyaluronate) (P010029/S026) | Ferring Pharmaceuticals, Inc. | 2018-04-26 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S061) | Ahp Eos Buyer, Inc. | 2018-04-26 |
| Precision Spinal Cord Stimulator System (P030017/S313) | Boston Scientific Corp | 2018-04-26 |
| ITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S311) | Medtronic Neuromodulation | 2018-04-26 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S050) | Ahp Eos Buyer, Inc. | 2018-04-26 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S060) | ABBOTT MEDICAL | 2018-04-26 |
| coflex® Interlaminar Technology (P110008/S008) | Companion Spine France | 2018-04-25 |
| Ventak AV Acid Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste (P960040/S423) | Boston Scientific | 2018-04-25 |
| Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software (P030005/S175) | Guidant Corp. | 2018-04-25 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S002) | Biotronik AG | 2018-04-25 |
| Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S106) | Boston Scientific Corporation | 2018-04-25 |
| Assurity MRI, Endurity MRI (P140033/S028) | ABBOTT MEDICAL | 2018-04-25 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S297) | Medtronic, Inc. | 2018-04-25 |
| Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S482) | Boston Scientific Corp | 2018-04-25 |
| Allure RF, Allure Quadra RF, Allure Quadra, Allure, Quadra Allure MP,Quadra Allure MP RF (P030035/S168) | ABBOTT MEDICAL | 2018-04-25 |
| 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/S664) | Medtronic Cardiac Rhythm Disease Management | 2018-04-25 |
| Astron Pulsar/Pulsar-18 Stent System (P160025/S001) | Biotronik AG | 2018-04-25 |
| Hoya iSert, Clarisert Intraocular Lens (P080004/S022) | Hoya Surgical Optics, Inc. | 2018-04-25 |
| Artic Front Advance Cardiac CryoAblation Catheter (P100010/S078) | Medtronic Cryocath, LP | 2018-04-25 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S026) | Abbott Diabetes Care, Inc. | 2018-04-25 |
| Assurity, Assurity +, Endurity, Endurity Core (P880086/S297) | ABBOTT MEDICAL | 2018-04-25 |
| Acuity Steerable Lead System (P050046/S028) | Guidant Corp. | 2018-04-25 |
| SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System (P030011/S061) | Syncardia Systems, LLC | 2018-04-25 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings (P840062/S065) | Integra Lifesciences Corp. | 2018-04-25 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S058) | Boston Scientific | 2018-04-25 |
| Ellipse VR, Ellipse DR, Fortify, Fortify Assura (P910023/S408) | ABBOTT MEDICAL | 2018-04-25 |
| Ventak(R) PRX (TM) Model 1700,1705 Pulse Generator (P910077/S166) | Boston Scientific | 2018-04-25 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S353) | ABBOTT MEDICAL | 2018-04-25 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S082) | Boston Scientific | 2018-04-25 |
| Thinline Endocardial Pacing Leads (P960004/S083) | Boston Scientific | 2018-04-25 |
| SynchroMed Infusion System (P860004/S301) | Medtronic, Inc. | 2018-04-25 |
| Ventak(R) P2 System (P930035/S029) | Boston Scientific | 2018-04-25 |
| 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/S622) | Medtronic Cardiac Rhythm Disease Management | 2018-04-25 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template Intergra, Ominigraft Dermal Regenerati (P900033/S069) | Integra Lifesciences Corp. | 2018-04-25 |
| Hilistat, Helitene, Absorbable Collagen Hemostatic Agents (P850010/S080) | Integra LifeSciences Corporation | 2018-04-25 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S121) | MicroPort CRM USA, Inc. | 2018-04-25 |
| Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal (P080011/S068) | CooperVision, Inc. | 2018-04-25 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S004) | Biotronik AG | 2018-04-25 |
| Endotak Lead System (P910073/S148) | Boston Scientific | 2018-04-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S363) | Medtronic, Inc. | 2018-04-25 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S228) | Boston Scientific Corp | 2018-04-25 |
| Paradym RF CRT-d 9750, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium 4 LV CRT-D 1744 (P060027/S095) | MicroPort CRM USA, Inc. | 2018-04-25 |
| Sweet Tip(R) RX Steroid Eluting Lead (P960006/S047) | Boston Scientific | 2018-04-25 |
| Revo MRI SureScan IPG (P090013/S275) | Medtronic, Inc. | 2018-04-25 |
| Paradym RF VR 9250, Paradym RF DR 9550, Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540 (P980049/S130) | MicroPort CRM USA, Inc. | 2018-04-25 |