| Pulse Generator, Permanent Implantable (P950037/S173) | Biotronik, Inc. | 2017-05-06 |
| MEDTRONIC ATTAIN ABILITY MRI SURESCAN, ATTAIN PERFORMA MRI SURESCAN LEAD (P080006/S105) | Medtronic, Inc. | 2017-05-06 |
| CAPSURE SENSE MRI SURESCAN LEAD (P830061/S140) | Medtronic Cardiac Rhythm Disease Management | 2017-05-06 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S007) | ABBOTT MEDICAL | 2017-05-05 |
| Cadence(R) Tiered Therapy Defribilation System (P910023/S385) | ABBOTT MEDICAL | 2017-05-05 |
| MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) (P110002/S015) | Highridge Medical, LLC | 2017-05-05 |
| Radiesse Injectable Implant (P050037/S079) | Merz North America, Inc. | 2017-05-05 |
| St Jude Medical Epic HF System (P030054/S328) | ABBOTT MEDICAL | 2017-05-05 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT_P) (P070008/S081) | Biotronik, Inc. | 2017-05-05 |
| MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) (P110009/S015) | Highridge Medical, LLC | 2017-05-05 |
| Inspire Upper Airway Stimulation (UAS) System, Model 3028 IPG (P130008/S016) | Inspire Medical Systems | 2017-05-05 |
| Anthem And Frontier II CRT-P'S (P030035/S156) | ABBOTT MEDICAL | 2017-05-05 |
| Micra Transcatheter Pacing System (P150033/S020) | Medtronic, Inc. | 2017-05-05 |
| Accent, Identity, Verity, Victory And Zephyr Pacemakers (P880086/S282) | ABBOTT MEDICAL | 2017-05-05 |
| iWear oxygen and iWear oxygen astigmatism (P080011/S058) | CooperVision, Inc. | 2017-05-05 |
| Radiesse (+) Lidocaine Dermal Filler (P050052/S093) | Merz North America, Inc. | 2017-05-05 |
| Maestro 4000 Cardiac Ablation System (Controller, Remote and Pods) (P020025/S099) | Boston Scientific | 2017-05-04 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P050023/S105) | Biotronik, Inc. | 2017-05-04 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S070) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-05-04 |
| Vistakon (etafilcon A) Brand Contact Lenses (N18033/S090) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-05-04 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P000009/S070) | Biotronik, Inc. | 2017-05-04 |
| Rotablator Rotational Atherectomy System (P900056/S159) | Boston Scientific Corp | 2017-05-04 |
| Dexom G4 PLATINUM Continuous Glucose Monitoring System (P120005/S062) | Dexcom, Inc. | 2017-05-04 |
| PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS (P950037/S171) | Biotronik, Inc. | 2017-05-04 |
| Aptima HPV Assay (P100042/S012) | Gen-Probe Incorporated | 2017-05-04 |
| Aptima HPV 16 18/45 Genotype Assay. (P120007/S010) | Gen-Probe Incorporated | 2017-05-04 |
| PACEMAKER ICD CRT NON IMPLANTED COMPONENTS (P070008/S079) | Biotronik, Inc. | 2017-05-04 |
| AcrySof® Single Piece Intraocular Lenses (P930014/S101) | Alcon Laboratories, Inc. | 2017-05-03 |
| Activa Deep Brain Stimulation Therapy System (P960009/S276) | Medtronic, Inc. | 2017-05-03 |
| InterStim Therapy System (P080025/S135) | Medtronic Neuromodulation | 2017-05-03 |
| Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0 (P000009/S068) | Biotronik, Inc. | 2017-05-03 |
| AcrySof® IQ ReSTOR® Intraocular Lenses (P040020/S069) | Alcon Research, Ltd. | 2017-05-03 |
| Restore and Itrel Spinal Cord Stimulation Systems (P840001/S357) | Medtronic Neuromodulation | 2017-05-03 |
| Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in (P050023/S103) | Biotronik, Inc. | 2017-05-03 |
| SynchroMed Infusion System (P860004/S272) | Medtronic, Inc. | 2017-05-03 |
| Wearable Defibrillator Life Vest (P010030/S095) | Zoll Manufacturing Corporation | 2017-05-03 |
| Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0 (P070008/S075) | Biotronik, Inc. | 2017-05-03 |
| PD-L1 IHC 28-8 pharmDx (P150025/S005) | Agilent Technologies, Inc. | 2017-05-03 |
| TactiCath Quartz Set (P130026/S023) | St Jude Medical | 2017-05-03 |
| Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0 (P950037/S166) | Biotronik, Inc. | 2017-05-03 |
| Diamondback 360 Coronary Orbital Atherectomy Device (OAD) (P130005/S016) | Cardiovascular Systems, Inc. | 2017-05-03 |
| InterStim Therapy System (P970004/S240) | Medtronic Neuromodulation | 2017-05-03 |
| Axium Neurostimulator System (P150004/S009) | ABBOTT MEDICAL | 2017-05-03 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S022) | Cook Ireland, Ltd. | 2017-05-02 |
| NeuroPace RNS System (P100026/S049) | NeuroPace, Inc. | 2017-05-02 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S091) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-05-02 |
| NG4 Family of Pulse Generators ICDS. (P960040/S385) | Boston Scientific | 2017-05-02 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S071) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-05-02 |
| AFX Endovascular AAA System (P040002/S059) | Endologix, LLC | 2017-05-02 |
| NG4 Family of Pulse Generators CRT-DS (P010012/S436) | Boston Scientific Corp | 2017-05-02 |
| Therakos CELLEX and UVAR XTS Procedural Kits (P860003/S088) | Therakos Development Limited | 2017-05-02 |
| Essentio, Proponent, Accolade MRI. (P150012/S028) | Boston Scientific | 2017-05-01 |
| EDWARDS INTUITY VALVE SYSTEM (P150036/S001) | Edwards Lifesciences, LLC | 2017-05-01 |
| Valitude, Visionist (P030005/S154) | Guidant Corp. | 2017-05-01 |
| Mentor, Mermorygel, Breast Implants (P030053/S041) | Mentor Corp. | 2017-05-01 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VAlVE (P130009/S066) | Edwards Lifesciences, LLC | 2017-05-01 |
| Mentor Memoryshape, Breast Implants (P060028/S023) | Mentor Worldwide, LLC | 2017-05-01 |
| Infinity Neurostimulation System (P140009/S023) | ABBOTT MEDICAL | 2017-05-01 |
| EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057/S154) | Edwards Lifesciences, LLC | 2017-05-01 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S015) | Bolton Medical, Inc. | 2017-05-01 |
| SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S025) | Edwards Lifesciences, LLC | 2017-05-01 |
| VENTANA PD-L1 (SP263) ASSAY (P160046) | Ventana Medical Systems, Inc. | 2017-05-01 |
| Pacemaker Models Advantio & Ingenio (N970003/S205) | Boston Scientific Corp | 2017-05-01 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S015) | Medtronic, Inc. | 2017-05-01 |
| ORBERA Intragastric Balloon System (P140008/S005) | Boston Scientific Corporation | 2017-05-01 |
| Essento, Proponent, Accolade, Altrua (N970003/S206) | Boston Scientific Corp | 2017-05-01 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |
| Mentor Saline Filled and Spectrum Breast Implants (P990075/S040) | Mentor Worldwide, LLC | 2017-05-01 |
| Cardiac Resynchronization Therapy Pacemaker Models Invive & Intua (P030005/S153) | Guidant Corp. | 2017-05-01 |
| AMS 700 Implantable Penile Prosthesis with InhibiZone Treatment, AMS 700 Implantable Penile Prosthesis without InhibiZon (N970012/S134) | Boston Scientific Corp | 2017-04-28 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S325) | Medtronic, Inc. | 2017-04-28 |
| VNS THERAPY SYSTEM (P970003/S198) | LivaNova USA, Inc. | 2017-04-28 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Max (P980016/S629) | Medtronic Cardiac Rhythm Disease Management | 2017-04-28 |
| RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043) | Medtronic Vascular | 2017-04-28 |
| 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/S589) | Medtronic Cardiac Rhythm Disease Management | 2017-04-28 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040) | Invivoscribe Technologies, Inc. | 2017-04-28 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S278) | Boston Scientific Corp | 2017-04-28 |
| Micra TPS (P150033/S022) | Medtronic, Inc. | 2017-04-28 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG,Advisa DR MRI IPG, Advisa SR MRI IPG, Relia IPG (P980035/S494) | Medtronic, Inc. | 2017-04-28 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S075) | Boston Scientific Corp | 2017-04-28 |
| MitraClip Delivery System (P100009/S023) | ABBOTT MEDICAL | 2017-04-28 |
| Revo MRI SureScan IPG (P090013/S253) | Medtronic, Inc. | 2017-04-28 |
| Paradigm Real-Time Reveal System (P150019/S028) | Medtronic Minimed | 2017-04-27 |
| MiniMed 630G System With SmartGuard (P150001/S012) | Medtronic Minimed | 2017-04-27 |
| iPro2 CGM System with Enlite Sensor (P150029/S008) | Medtronic Minimed | 2017-04-27 |
| Artificial Pancreas Device System Threshold Suspend (P120010/S102) | Medtronic, Inc. | 2017-04-27 |
| AngioJet Ultra Thrombecomy System Conosle (P980037/S064) | Boston Scientific Corp | 2017-04-27 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM, INSTRUMENT, LIGHT ASSEMBLY, PROCEDURAL KIT. (P860003/S087) | Therakos Development Limited | 2017-04-27 |
| MiniMed 670G System (P160017/S011) | Medtronic Minimed, Inc. | 2017-04-27 |
| AMS 700 Implanted Penile Prosthesis (N970012/S128) | Boston Scientific Corp | 2017-04-27 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S326) | Medtronic, Inc. | 2017-04-26 |
| RADIESSE INJECTABLE IMPLANT (DERMAL FILLERS) (P050052/S091) | Merz North America, Inc. | 2017-04-26 |
| Evera, Visia MRI ICD, S VR ICD, XT VR ICD (P980016/S628) | Medtronic Cardiac Rhythm Disease Management | 2017-04-26 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S005) | Abbott Diabetes Care, Inc. | 2017-04-26 |
| ADVIA CENTAUR IMMUNOASSAY (P930036/S007) | Siemens Healthcare Diagnostics, Inc. | 2017-04-26 |
| Amplia, Amplia MRI Quad, Brava, Brava MRI Quad, Claria MRI, Compia, Viva XT CRT-D (P010031/S588) | Medtronic Cardiac Rhythm Disease Management | 2017-04-26 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-D (P010015/S324) | Medtronic, Inc. | 2017-04-26 |
| Aesculap Implant Systems (P120024/S005) | Highridge Medical, LLC | 2017-04-26 |
| Advisia DR IPG, Advisia DR/SR MRI IPG (P980035/S493) | Medtronic, Inc. | 2017-04-26 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S355) | Medtronic Neuromodulation | 2017-04-26 |