| artus CMV RGQ MDx Kit and artus CMV QS_RGQ MDx Kit (P130027/S005) | Qiagen, Inc. | 2018-04-06 |
| Astra XT DR, Astra S DR, Astra S SR, Astra XT SR, Azure S DR, Azure S SR, Azure XT DR, Azure XT SR MRI IPG (P980035/S541) | Medtronic, Inc. | 2018-04-06 |
| Medtronic CoreValve System / Medtronic CoreValve Evolut R System/ Medtronic CoreValve Evolut PRO System (P130021/S041) | Medtronic, Inc. | 2018-04-06 |
| FoundationFocus CDx BRCA HRD (P160018/S001) | Foundation Medicine, Inc. | 2018-04-06 |
| therascreen KRAS RGQ PCR Kit (P110027/S010) | QIAGEN GmbH | 2018-04-06 |
| therascreen EGFR RGQ PCR Kit (P120022/S019) | QIAGEN GmbH | 2018-04-06 |
| Bellafil Dermal Filler (P020012/S022) | Tiger Aesthetics Medical, LLC | 2018-04-05 |
| Juvederm Injectable Gel Implants (P110033/S037) | Allergan | 2018-04-05 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S029) | Medinol, Ltd. | 2018-04-05 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S023) | Abbott Diabetes Care, Inc. | 2018-04-05 |
| INGEVITY MRI Active Fixation Lead Models (P150012/S056) | Boston Scientific | 2018-04-05 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S013) | Abbott Diabetes Care, Inc. | 2018-04-05 |
| Integra Dermal Regeneration Template (P900033/S068) | Integra Lifesciences Corp. | 2018-04-05 |
| Juvederm Injectable Gel Implants (P050047/S063) | Allergan | 2018-04-05 |
| EluNIR™ Ridaforolimus Eluting Coronary Stent System (P170008/S003) | Medinol, Ltd. | 2018-04-05 |
| TactiCath Quartz Set (P130026/S033) | St Jude Medical | 2018-04-04 |
| CardioMEMS HF System (P100045/S023) | ABBOTT MEDICAL | 2018-04-04 |
| Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, CD3257-40Q, CD3357-40, CD3357-4 (P030054/S351) | ABBOTT MEDICAL | 2018-04-04 |
| Fortify Models CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Assura Models CD1257-40, CD1257-40Q, CD2257-40, CD2 (P910023/S406) | ABBOTT MEDICAL | 2018-04-04 |
| Epic Vascular Self-Expanding Stent System (P110035/S045) | Boston Scientific Corp | 2018-04-03 |
| Protecta ICD, Protecta VR ICD, ProtectaXT ICD, Secura DR ICD, Secura ICD (P980016/S660) | Medtronic Cardiac Rhythm Disease Management | 2018-04-03 |
| Angio Seal Vascular Closure Devices (P930038/S087) | Terumo Medical Corporation | 2018-04-03 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S358) | Medtronic, Inc. | 2018-04-03 |
| Forify, Fortify Assura (P910023/S407) | ABBOTT MEDICAL | 2018-04-03 |
| CapSure Fix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S181) | Medtronic, Inc. | 2018-04-03 |
| CapSure Fix MRI Lead (P090013/S271) | Medtronic, Inc. | 2018-04-03 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S538) | Medtronic, Inc. | 2018-04-03 |
| Belotero Balance Dermal Filler (P090016/S027) | Merz North America, Inc. | 2018-04-03 |
| VenaSeal Closure System (P140018/S010) | Medtronic Vascular, Inc. | 2018-04-03 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura and Quadra Assura MP (P030054/S352) | ABBOTT MEDICAL | 2018-04-03 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S096) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-04-03 |
| Consulta CRT-D, Procteca CRT-D, Protecta XT CRT-D (P010031/S619) | Medtronic Cardiac Rhythm Disease Management | 2018-04-03 |
| Tendril SDX/ST/STS and Optisense Leads (LV Active) (P960013/S090) | ABBOTT MEDICAL | 2018-04-02 |
| Advisa DR IPG, Advisa DR MIR IPG and Advisa SR MRI IPG (P980035/S532) | Medtronic, Inc. | 2018-04-02 |
| QuickFlex u and Quartet leads (P030054/S323) | ABBOTT MEDICAL | 2018-04-02 |
| Tendril MRI Leads (MRI) (P140033/S002) | ABBOTT MEDICAL | 2018-04-02 |
| Consulta , Syncra and Viva CRT-P (P010015/S353) | Medtronic, Inc. | 2018-04-02 |
| Durata and Optisure Leads (HV Active and Passive) (P950022/S102) | ABBOTT MEDICAL | 2018-04-02 |
| Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment System (P030017/S312) | Boston Scientific Corp | 2018-04-02 |
| IsoFlex Optim Leads (lV Passive) (P960030/S052) | ABBOTT MEDICAL | 2018-04-02 |
| Belotero Balance Dermal Filler (P090016/S026) | Merz North America, Inc. | 2018-04-02 |
| LiveWire TC Steerable Electrophysiology Catheter (P960016/S074) | St Jude Medical | 2018-04-02 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S048) | Ahp Eos Buyer, Inc. | 2018-03-30 |
| GORE CARDIOFORM Septal Occluder (P050006/S060) | W. L. Gore & Associates, Inc. | 2018-03-30 |
| VASCADE VASCULAR CLOSURE SYSTEM (VCS) (P120016/S021) | Cardiva Medical, Inc. | 2018-03-30 |
| Inlexa 7 VR-T, Inlexa 3 VR-T, Llivia 7 VR-T, Intica 7 VR-T, Intica 5 VR-T, Iperia 7 VR-T, Itrevia 5 VR-T, Inventra 7 VR- (P050023/S118) | Biotronik, Inc. | 2018-03-30 |
| Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System (P850022/S029) | Ahp Eos Buyer, Inc. | 2018-03-30 |
| Biomet EBI Bone Healing System (P790002/S037) | Ahp Eos Buyer, Inc. | 2018-03-30 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S059) | Ahp Eos Buyer, Inc. | 2018-03-30 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S060) | Edwards Lifesciences, LLC | 2018-03-29 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S011) | Abbott Diabetes Care, Inc. | 2018-03-29 |
| LiveWire TC Steerable Electrophysiology Catheter (P960016/S073) | St Jude Medical | 2018-03-29 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S060) | Ahp Eos Buyer, Inc. | 2018-03-29 |
| Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S032) | ABBOTT MEDICAL | 2018-03-29 |
| NexGen LPS-Flex / LPS Mobile Bearing Knee System (P060037/S055) | Zimmer, Inc. | 2018-03-29 |
| FreeStyle Libre Pro Flassh Glucose Monitoring System (P150021/S021) | Abbott Diabetes Care, Inc. | 2018-03-29 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S049) | Ahp Eos Buyer, Inc. | 2018-03-29 |
| ELCA Laser Catheters (P910001/S103) | Spectranetics Corp. | 2018-03-29 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis/with ThermaFix tissue process; Carpentier-Edwards PE (P860057/S176) | Edwards Lifesciences, LLC | 2018-03-29 |
| Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S085) | Edwards Lifesciences, LLC | 2018-03-29 |
| Edwards Intuity Elite Valve System (P150036/S026) | Edwards Lifesciences, LLC | 2018-03-29 |
| Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S072) | CooperVision, Inc. | 2018-03-29 |
| PureVision (balafilcon A) Visibility Tinted Contact Lens (P980006/S026) | Bausch & Lomb, Inc. | 2018-03-29 |
| Radiesse Hands, Radiesse (+) Lidocaine (P050052/S098) | Merz North America, Inc. | 2018-03-28 |
| Belotero Balance Dermal Filler (P090016/S025) | Merz North America, Inc. | 2018-03-28 |
| WEBSTER Catheter / CELSIUS Catheter (P950005/S069) | Biosense Webster, Inc. | 2018-03-28 |
| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S063) | Edwards Lifesciences, LLC | 2018-03-28 |
| TRYTON Side Branch Stent (P150039/S003) | Poseidon Medical, Inc. | 2018-03-28 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S038) | Boston Scientific Corporation | 2018-03-28 |
| Mitroflow Aortic Pericardial Heart Valve (P060038/S031) | Corcym Canada Corp | 2018-03-28 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S088) | Edwards Lifesciences, LLC | 2018-03-28 |
| Coaptite Injectable Implant (P040047/S046) | Merz North America, Inc. | 2018-03-28 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM MRI S-ICD and S-ICD Pulse Generator (P110042/S105) | Boston Scientific Corporation | 2018-03-28 |
| Radiesse Injectable Implant (P050037/S082) | Merz North America, Inc. | 2018-03-28 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve (P150048/S018) | Edwards Lifesciences, LLC | 2018-03-27 |
| Edwards Intuity Elite Valve System (P150036/S027) | Edwards Lifesciences, LLC | 2018-03-27 |
| Cobas 4800 BRAF V600 Mutation Test (P110020/S024) | Roche Molecular Systems, Inc. | 2018-03-27 |
| Primo MRI DR/VR SureScan; Mirro MRI DR/VR SureScan (P980016/S659) | Medtronic Cardiac Rhythm Disease Management | 2018-03-27 |
| Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2 (P120019/S020) | Roche | 2018-03-27 |
| VenaSeal Closure System (P140018/S009) | Medtronic Vascular, Inc. | 2018-03-27 |
| QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus (P010033/S039) | Qiagen | 2018-03-27 |
| FreeStyle Libre Flash Glucose Monitoring System (P160030/S012) | Abbott Diabetes Care, Inc. | 2018-03-27 |
| Raindrop Near Vision Inlay (P150034/S005) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-03-27 |
| HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test (P890064/S040) | Qiagen Gaithersburg, Inc. | 2018-03-27 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S022) | Abbott Diabetes Care, Inc. | 2018-03-27 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Carpentier-Edwards Perimount Theon Percardial Aortic Biop (P860057/S175) | Edwards Lifesciences, LLC | 2018-03-27 |
| Dexcom G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems (P120005/S071) | Dexcom, Inc. | 2018-03-27 |
| Cobas KRAS Mutation Test (P140023/S013) | Roche Molecular Systems, Inc. | 2018-03-27 |
| Durata and Optisre Family of High Voltage Leads (P950022/S116) | ABBOTT MEDICAL | 2018-03-27 |
| LIPOSORBER LA-15 System (P910018/S024) | Kaneka Pharma America Corp. | 2018-03-26 |
| Gore Cardioform Septal Occluder (P050006/S062) | W. L. Gore & Associates, Inc. | 2018-03-26 |
| Praxis Extended RAS Panel (P160038/S002) | Illumina, Inc. | 2018-03-26 |
| Latitude Programming System (P910077/S165) | Boston Scientific | 2018-03-26 |
| Invive, Intua, Visionist, Valitude (P030005/S172) | Guidant Corp. | 2018-03-26 |
| Cobas HPV Test (P100020/S029) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigiliant, Perciva (P010012/S477) | Boston Scientific Corp | 2018-03-26 |
| TactiCath Quartz Set (P130026/S028) | St Jude Medical | 2018-03-26 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S034) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Cobas CMV Test (P160041/S007) | Roche Molecular Systems, Inc. | 2018-03-26 |
| Ceramax Ceramic Total Hip System (P070026/S052) | DePuy Orthopaedics, Inc. | 2018-03-26 |