| MOBI-C Cervical Disc Prosthesis (P110002/S019) | Highridge Medical, LLC | 2017-06-02 |
| AngioJet Rheolytic Thrombectomy System (P980037/S065) | Boston Scientific Corp | 2017-06-02 |
| Endologix Powerlink System (P040002/S058) | Endologix, LLC | 2017-06-02 |
| ARTUS CMV RGQ MDX KIT (P130027/S002) | Qiagen, Inc. | 2017-06-02 |
| COBAS CMV (P160041) | Roche Molecular Systems, Inc. | 2017-06-01 |
| Intella Tip MiFi XP cardiac ablation catheters (P020025/S098) | Boston Scientific | 2017-06-01 |
| Precision Spinal Cord Stimulation (SCS) System (P030017/S288) | Boston Scientific Corp | 2017-06-01 |
| Combi 40+ Cochlear Implant System (P000025/S095) | Med-El Corp. | 2017-06-01 |
| FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021/S004) | Abbott Diabetes Care, Inc. | 2017-05-31 |
| SynchroMed Infusion System (P860004/S278) | Medtronic, Inc. | 2017-05-31 |
| PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM (P030017/S269) | Boston Scientific Corp | 2017-05-31 |
| Prometra Programmable Infusion Pump System (P080012/S041) | Infusyn Therapeutics, LLC | 2017-05-31 |
| Adapta, Versa, Sensia IPG ADSR01, ADDR01, ADDR06, ADDRL1, ADDRS1, VEDR01, ADD01, SEDRL1, SED01, SES01, ADDR03, SEDR01, A (P980035/S498) | Medtronic, Inc. | 2017-05-30 |
| SURGIFOAM Absorbable Gelatin Sponge (P990004/S031) | Ferrosan Meidcal Devices A/S | 2017-05-30 |
| Propel Sinus Implant & Propel mini Sinus Implant (P100044/S027) | Intersect Ent. | 2017-05-30 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S045) | ABBOTT MEDICAL | 2017-05-30 |
| Vaisala Environmental Monitoring System (P110016/S044) | ABBOTT MEDICAL | 2017-05-26 |
| Innova Self-Expanding Stent System (P140028/S025) | Boston Scientific Corporation | 2017-05-26 |
| SynchroMed II (Model 8637) pump (P860004/S276) | Medtronic, Inc. | 2017-05-26 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S005) | Ventana Medical Systems, Inc. | 2017-05-26 |
| Sterishot II Mini Flishie Clip Applicator (P920046/S010) | Femcare , Ltd. | 2017-05-26 |
| Epic Vascular Self-Expanding Stent System (P110035/S040) | Boston Scientific Corp | 2017-05-26 |
| AED Plus and Fully Automatic AED Plus (P160015) | ZOLL Medical Corporation | 2017-05-26 |
| Hydro Thermablator Endometrial Ablation System (P000040/S036) | Axora Medical, Inc. | 2017-05-26 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S161) | Boston Scientific Corp | 2017-05-26 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S030) | Boston Scientific Corporation | 2017-05-26 |
| SURGICEL POWDER ABSORBABLE HEMOSTATIC POWDER (N12159/S036) | ETHICON, Inc. | 2017-05-26 |
| MynxGrip Vascular Closure Device (P040044/S076) | Cordis US Corporation | 2017-05-26 |
| Juvéderm Injectable Gel Implants (P050047/S060) | Allergan | 2017-05-25 |
| InterStim Therapy System (Urinary) (P970004/S243) | Medtronic Neuromodulation | 2017-05-25 |
| InterStim Therapy System (Urinary) (P970004/S242) | Medtronic Neuromodulation | 2017-05-25 |
| DiaSorin ETI-AB-EBK PLUS assay (P990041/S021) | DiaSorin, Inc. | 2017-05-25 |
| InterStim Therapy System (Bowel) (P080025/S137) | Medtronic Neuromodulation | 2017-05-25 |
| Activa Deep Brain Stimulation Therapy System (P960009/S281) | Medtronic, Inc. | 2017-05-25 |
| SynchroMed Infusion System (P860004/S277) | Medtronic, Inc. | 2017-05-25 |
| Restore, Itrel and Synergy Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord Stimulation Lead (P840001/S361) | Medtronic Neuromodulation | 2017-05-25 |
| DiaSorin ETI-CORE-IGMK PLUS assay (P990044/S019) | DiaSorin, Inc. | 2017-05-25 |
| Activa Deep Brain Stimulation Therapy System. (P960009/S280) | Medtronic, Inc. | 2017-05-25 |
| InterStim Therapy System (Bowel) (P080025/S138) | Medtronic Neuromodulation | 2017-05-25 |
| DiaSorin ETI-AB-COREK PLUS assay (P990045/S019) | DiaSorin, Inc. | 2017-05-25 |
| DiaSorin ETI-MAK-2 PLUS (P990038/S022) | DiaSorin, Inc. | 2017-05-25 |
| Juvéderm Voluma XC, Juvéderm VollureTM XC, Juvéderm Volbella XC (P110033/S030) | Allergan | 2017-05-25 |
| DiaSorin ETI-AB-AUK PLUS assay (P990042/S018) | DiaSorin, Inc. | 2017-05-25 |
| Edwards Intuity Elite Valve & Delivery System (P150036/S010) | Edwards Lifesciences, LLC | 2017-05-25 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads (P840001/S362) | Medtronic Neuromodulation | 2017-05-25 |
| DiaSorin ETI-EBK PLUS assay (P990043/S022) | DiaSorin, Inc. | 2017-05-25 |
| Mentor Saline-Filled and SPECTRUM® Breast Implants (P990075/S041) | Mentor Worldwide, LLC | 2017-05-24 |
| Solia S (P950037/S174) | Biotronik, Inc. | 2017-05-24 |
| Cologuard (P130017/S015) | Exact Sciences Corporation | 2017-05-24 |
| Mentor MemoryGel® Silicone Gel-Filled Breast Implants (P030053/S042) | Mentor Corp. | 2017-05-24 |
| Mentor MemoryShape Breast Implants (P060028/S024) | Mentor Worldwide, LLC | 2017-05-24 |
| Algovita Spinal Cord Stimulation System (P130028/S017) | Nuvectra Corporation | 2017-05-24 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S048) | Syncardia Systems, LLC | 2017-05-24 |
| TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1-Piece IOLs, TECNIS Toric 1-Piece IOLs, TECNIS Toric (P980040/S081) | Johnson & Johnson Surgical Vision, Inc. | 2017-05-24 |
| Intersect ENT Propel Contour Sinus Implant Component Verification System Generation II (P100044/S028) | Intersect Ent. | 2017-05-24 |
| Maestro Rechargeable System (P130019/S014) | Reshape Lifesciences, Inc. | 2017-05-24 |
| Esteem (P090018/S034) | Envoy Medical Corporation | 2017-05-24 |
| Plexa S 60/Plexa SD 60/16/Plexa ProMRI S/Plexa ProMRI SD/Plexa DF-1 S/Plexa DF-1 SD/Plexa ProMRI DF-1 SD/Plexa ProMRI DF (P980023/S081) | Biotronik, Inc. | 2017-05-24 |
| Mobi-C Cervical Disc Prosthesis for use at One or Two Levels (P110009/S018) | Highridge Medical, LLC | 2017-05-23 |
| Fineline II Sterox and Sterox EZ Lead (P960004/S080) | Boston Scientific | 2017-05-23 |
| InterStim Therapy System (Urinary) (P970004/S241) | Medtronic Neuromodulation | 2017-05-23 |
| Restore, Itrel, Spinal Cord Stimulation Systems (P840001/S360) | Medtronic Neuromodulation | 2017-05-23 |
| InterStim Therapy System (Bowel) (P080025/S136) | Medtronic Neuromodulation | 2017-05-23 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S074) | Edwards Lifesciences, LLC | 2017-05-23 |
| Nucleus 24 Cochlear Implant System (P970051/S162) | Cochlear Americas | 2017-05-23 |
| Nucleus Hybrid Cochlear Implant System (P130016/S026) | Cochlear Americas | 2017-05-23 |
| ENVISTA IOL (P910056/S024) | Bausch & Lomb, Inc. | 2017-05-23 |
| MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) (P110002/S018) | Highridge Medical, LLC | 2017-05-23 |
| ETI MAK-2 PLUS and HBsAg Confirmatory Test assays (P990038/S023) | DiaSorin, Inc. | 2017-05-23 |
| Juvederm Injectable Gel Implants (P050047/S059) | Allergan | 2017-05-23 |
| ETI-EBK PLUS assay (P990043/S023) | DiaSorin, Inc. | 2017-05-23 |
| Ingevity Lead (P150012/S030) | Boston Scientific | 2017-05-23 |
| ETI-AB-EBK PLUS assay (P990041/S022) | DiaSorin, Inc. | 2017-05-23 |
| ETI-AB-AUK PLUS assay (P990042/S019) | DiaSorin, Inc. | 2017-05-23 |
| Selenia Dimensions 3D System. (P080003/S005) | Hologic, Inc. | 2017-05-23 |
| ETI-CORE-IGMK PLUS assay (P990044/S020) | DiaSorin, Inc. | 2017-05-23 |
| LIPOSORBER(R) LA-15 SYSTEM (P910018/S022) | Kaneka Pharma America Corp. | 2017-05-23 |
| SynchroMed Infusion System (P860004/S274) | Medtronic, Inc. | 2017-05-23 |
| Activa Deep Brain Stimulation Therapy System (P960009/S279) | Medtronic, Inc. | 2017-05-23 |
| ETI-AB-COREK PLUS assay (P990045/S020) | DiaSorin, Inc. | 2017-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S039) | Edwards Lifesciences, LLC | 2017-05-23 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bio (P860057/S160) | Edwards Lifesciences, LLC | 2017-05-23 |
| Juvederm Injectable Gel Implants (P110033/S029) | Allergan | 2017-05-23 |
| EDWARDS INTUITY Valve System (P150036/S008) | Edwards Lifesciences, LLC | 2017-05-23 |
| EMBLEM S-ICD Pulse Generator (PG) & MRI S-ICD Pulse Generator (PG) (S-ICD's) (P110042/S084) | Boston Scientific Corporation | 2017-05-23 |
| DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S059) | Dexcom, Inc. | 2017-05-22 |
| Dimension FPSA Flex reagent cartridge (RF452) (P020027/S026) | Siemens Healthcare Diagnostics | 2017-05-22 |
| Dimension TPSA Flex reagent cartridge (RF451) (P000021/S031) | Siemens Healthcare Diagnostics | 2017-05-22 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S043) | ABBOTT MEDICAL | 2017-05-22 |
| MELODY TRANSCATHETER PULMONARY VALVE , ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S006) | Medtronic, Inc. | 2017-05-22 |
| Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo SP Ablation Catheter (P110016/S046) | ABBOTT MEDICAL | 2017-05-19 |
| Ingevity Lead Manufacturing Changes (P150012/S029) | Boston Scientific | 2017-05-19 |
| Melody Transcatheter Pulmonary Valve System (P140017/S007) | Medtronic, Inc. | 2017-05-19 |
| Restore Spinal Cord Stimulation Systems (P840001/S359) | Medtronic Neuromodulation | 2017-05-19 |
| Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter, Safire TX Ablation Catheter (P040042/S037) | Irvine Biomedical,Inc.(Ibi) | 2017-05-19 |
| Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App (P110042/S080) | Boston Scientific Corporation | 2017-05-19 |
| Therapy Cool Path Ablation Catheters, Therapy Cool Path SP Ablation Catheter and Safire BLU SP Ablation Catheter (P060019/S039) | Irvine Biomedical, Inc. | 2017-05-19 |
| Angio Seal Vascular Closure Device (P930038/S083) | Terumo Medical Corporation | 2017-05-19 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S019) | ABBOTT MEDICAL | 2017-05-19 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant FreeFlo Tapered Stent Graft Configurations (P100040/S031) | Medtronic Vascular | 2017-05-19 |