| Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled (P110016/S060) | ABBOTT MEDICAL | 2019-04-11 |
| BOND Oracle HER2 IHC System (P090015/S007) | Leica Biosystems | 2019-04-11 |
| Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear; Euclid Systems ORthokeratology (tisilfoc (P040029/S007) | Euclid Vision Corporation | 2019-04-11 |
| Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat (P040042/S042) | Irvine Biomedical,Inc.(Ibi) | 2019-04-11 |
| Tack Endovascular System (6F) (P180034) | Philips Image Guided Therapy Corporation | 2019-04-11 |
| Therapy Cool Path Ablation Catheter (P060019/S045) | Irvine Biomedical, Inc. | 2019-04-11 |
| Amplia MRI Quad CRT-D SureScan, Compia MRI Quad CRT-D SureScan, Claria MRI Quad CRT-D SureScan and Implantable Defibrill (P010031/S654) | Medtronic Cardiac Rhythm Disease Management | 2019-04-10 |
| COBAS AmpliPrep/COBAS TaqMan HBV, v2.0 (P050028/S074) | Roche Molecular Systems, Inc. | 2019-04-10 |
| RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S003) | Teoxane S.A. | 2019-04-10 |
| FoundationOne CDx Assay (P170019/S005) | Foundation Medicine, Inc. | 2019-04-10 |
| Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScaan Lead and Sprint Quattro MRI SureScan Lead (P920015/S222) | Medtronic, Inc. | 2019-04-10 |
| CapSureFix MRI SureScan Lead (P090013/S293) | Medtronic, Inc. | 2019-04-10 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S073) | Roche Molecular Systems, Inc. | 2019-04-10 |
| SelectSecure MRI SureScan Lead (P030036/S106) | Medtronic Cardiac Rhythm Disease Management | 2019-04-10 |
| COBAS® AmpliPrep/COBAS TaqMan CV Test (P110037/S045) | Roche Molecular Systems, Inc. | 2019-04-10 |
| Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C (P130005/S025) | Cardiovascular Systems, Inc. | 2019-04-10 |
| Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan and Implantable Pulse G (P010015/S385) | Medtronic, Inc. | 2019-04-10 |
| CapSure Sense MRI SureScan Lead (P830061/S165) | Medtronic Cardiac Rhythm Disease Management | 2019-04-10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S043) | St Jude Medical | 2019-04-10 |
| CapSureFix Novus MRI SureScan Lead (P930039/S194) | Medtronic, Inc. | 2019-04-10 |
| Attain Stability Quad MRI SureScan Lead (P080006/S129) | Medtronic, Inc. | 2019-04-10 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S016) | W. L. Gore & Associates, Inc. | 2019-04-09 |
| NeuroPace RNS System (P100026/S065) | NeuroPace, Inc. | 2019-04-09 |
| Biofinity XR Toric Lenses (P080011/S091) | CooperVision, Inc. | 2019-04-09 |
| Accessory Kit (P940031/S078) | Boston Scientific | 2019-04-08 |
| ACUITY X4 Straight 86CM ,95CM, ACUITY X4 Spiral S 86CM, 95CM, ACUITY X4 Spiral L 86CM, L95CM, Accessory Suture Sleeves S (P010012/S500) | Boston Scientific Corp | 2019-04-08 |
| HeartLight Endoscopic Ablation System (P150026/S005) | Cardiofocus, Inc. | 2019-04-08 |
| Accessory Stylet TAPER .014 45CM, .014 52CM, .014 58CM, .016 45CM, .016 52CM, and .016 58CM, Accessory Stylet TAPER .013 (P960004/S089) | Boston Scientific | 2019-04-08 |
| Accessory Wrench Socket Cap Brady/Tachy (N970003/S237) | Boston Scientific Corp | 2019-04-08 |
| Accessory Wrench (P930035/S030) | Boston Scientific | 2019-04-08 |
| Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR (P150012/S074) | Boston Scientific | 2019-04-08 |
| LV Lead Quadpole Connector IS4, Accessory Kit Lead Cap, Accessory Stylet TAPER FIX SOFT 64CM, 70CM, and 100CM, Accessory (P910073/S154) | Boston Scientific | 2019-04-08 |
| Accessory Hex Wrench (P840068/S054) | Boston Scientific | 2019-04-08 |
| Emblem S-ICD Electrode 45cm (P110042/S124) | Boston Scientific Corporation | 2019-04-08 |
| ZOOM LATTITUDE Programmer System Accessory Kit, Adapter Power RF COmmunicator, Accessory Kit Lead Cap, Accessory Wand T (P910077/S170) | Boston Scientific | 2019-04-08 |
| Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0 (P830060/S083) | Boston Scientific | 2019-04-08 |
| Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool (P960006/S049) | Boston Scientific | 2019-04-08 |
| Flash Glucose Monitoring System (P150021/S036) | Abbott Diabetes Care, Inc. | 2019-04-05 |
| Vercise Vercise PC, and Vercise Gevia, Deep Brain Stimulation (DBS) Systems (P150031/S017) | Boston Scientific Corp | 2019-04-05 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S003) | Fujirebio Europe N.V. | 2019-04-05 |
| Freestyle Libre Pro (P160030/S028) | Abbott Diabetes Care, Inc. | 2019-04-05 |
| RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD) (P160055/S004) | Rxsight, Inc. | 2019-04-05 |
| TECNIS CL Foldable Silicone Intraocular Lens (P880081/S042) | Johnson & Johnson Surgical Vision, Inc. | 2019-04-05 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spexctra WaveWriter Spinal Co (P030017/S325) | Boston Scientific Corp | 2019-04-05 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S102) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2019-04-05 |
| Bellafill Dermal Filler (P020012/S028) | Tiger Aesthetics Medical, LLC | 2019-04-05 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S105) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-04-05 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis (P150048/S032) | Edwards Lifesciences, LLC | 2019-04-04 |
| Juvederm Ultra XC and Ultra Plus XC (P050047/S068) | Allergan | 2019-04-04 |
| Cardiac Resynchronization Therapy Pacemakers (CRT-P) Percepta Bipolar CRT-P, Percepta Quadtripolar CRT-P; Serena Bipolar (P010015/S396) | Medtronic, Inc. | 2019-04-04 |
| CardioMEMS HF System (P100045/S036) | ABBOTT MEDICAL | 2019-04-04 |
| Implantable Pulse Generators (IPG) Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG; Azu (P980035/S580) | Medtronic, Inc. | 2019-04-04 |
| Juvederm Voluma XC, Vollure XC and Volbella XC (P110033/S043) | Allergan | 2019-04-04 |
| NuVasive PCM Cervical Disc (P100012/S008) | Nuvasive, Inc. | 2019-04-03 |
| AMS Ambicor Inflatable Penile Prosthesis (N970012/S160) | Boston Scientific Corp | 2019-04-03 |
| Arctic Fron Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters (P100010/S089) | Medtronic Cryocath, LP | 2019-04-03 |
| InterStim Therapy System Verify Evaluation System (SNS Bowel) (P080025/S180) | Medtronic Neuromodulation | 2019-04-02 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S020) | Boston Scientific Corp | 2019-04-02 |
| Activa Deep Brain Stimulation Therapy System (P960009/S343) | Medtronic, Inc. | 2019-04-02 |
| Vistag Surpoint External Process Unit (EPU) (P030031/S092) | Biosense Webster, Inc. | 2019-04-02 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S285) | Medtronic Neuromodulation | 2019-04-02 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S424) | Medtronic Neuromodulation | 2019-04-02 |
| Implantable System for Remodulin (P140032/S030) | Medtronic, Inc. | 2019-04-02 |
| TherOx Downstream System (P170027) | Zoll Circulation, Inc. | 2019-04-02 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S327) | Medtronic, Inc. | 2019-04-02 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S028) | Boston Scientific Corp | 2019-04-01 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S423) | Medtronic Neuromodulation | 2019-04-01 |
| TECNIS 3-Piece Acrylic Monofocal (P990080/S050) | Johnson & Johnson Surgical Vision, Inc. | 2019-04-01 |
| Activa Deep Brain Stimulation Therapy System (P960009/S342) | Medtronic, Inc. | 2019-04-01 |
| SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, Preloaded TECNIS 1-Piece IOL, TECNIS Multifocal 1-P (P980040/S102) | Johnson & Johnson Surgical Vision, Inc. | 2019-04-01 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S150) | Boston Scientific Corp | 2019-04-01 |
| SynchroMed Infusion System (P860004/S326) | Medtronic, Inc. | 2019-03-29 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S043) | Boston Scientific Corporation | 2019-03-29 |
| Implantable System for Remodulin (ISR) (P140032/S028) | Medtronic, Inc. | 2019-03-29 |
| AMS 800 Artificial Urinary Sphincter with and without Inhibizone Treatment (P000053/S102) | Boston Scientific Corp | 2019-03-29 |
| Angio Seal Vascular Closure Devices (P930038/S093) | Terumo Medical Corporation | 2019-03-29 |
| Cerene® Cryotherapy Device (P180032) | Channel Medsystems, Inc. | 2019-03-28 |
| C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric (P060011/S016) | Rayner Intraocular Lenses , Ltd. | 2019-03-28 |
| AMS Ambicor Inflatable Penile Prosthesis (N970012/S161) | Boston Scientific Corp | 2019-03-28 |
| AMS 800 Artificial Urinary Sphincter (with and without InhibiZone); AMS 700 Inflatable Penile Prosthesis (with and witho (P000053/S103) | Boston Scientific Corp | 2019-03-28 |
| LIPOSORBER LA-15 System (P910018/S023) | Kaneka Pharma America Corp. | 2019-03-28 |
| LifeVest Wearable Defibrillator (P010030/S116) | Zoll Manufacturing Corporation | 2019-03-27 |
| Capsular Tension Ring (CTR) (P030023/S007) | Ophtec BV | 2019-03-27 |
| CPR Stat-Padz Electrode and CPR-D Padz Electrode (P160015/S002) | ZOLL Medical Corporation | 2019-03-27 |
| Percepta Bipolar CRT-P, Quadripolar CRT-P, Serena Bipolar CRT-P, Quadripolar CRT-P, Solara Bipolar CRT-P, Quadripolar CR (P010015/S391) | Medtronic, Inc. | 2019-03-27 |
| LCS(R) Total Knee System (P830055/S210) | Depuy, Inc. | 2019-03-27 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S159) | Boston Scientific Corp | 2019-03-27 |
| Astra S DR MRI IPG, SR MRI IPG, Astra XT DR MRI IPG, SR MRI IPG, Azure S DR MRI IPG, SR MRI IPG, Azure XT DR MRI IPG, SR (P980035/S576) | Medtronic, Inc. | 2019-03-27 |
| SenTiva Model 1000 Generator (P970003/S221) | LivaNova USA, Inc. | 2019-03-27 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) plus generator (PG) devices (P110042/S122) | Boston Scientific Corporation | 2019-03-27 |
| SCS EPG Header (P010032/S147) | ABBOTT MEDICAL | 2019-03-26 |
| Myocardial Pacing Lead (P120017/S017) | Medtronic, Inc. | 2019-03-26 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S108) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| CapSure Epicardial Pacing Lead (P950024/S084) | Medtronic, Inc. | 2019-03-26 |
| Amplia MRI CRT-D, MRI Quad CRT-D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, MRI Quad CRT-D; Compia MRI CRT-D, MRI Quad (P010031/S659) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S394) | Medtronic, Inc. | 2019-03-26 |
| CapSure VDD 2 Lead, Service Kit-Pacemaker Repair Kit and Vitatron Brilliant S+ VDD Lead (P890003/S405) | Medtronic, Inc. | 2019-03-26 |
| TRILURON (P180040) | Fidia Farmaceutici S.P.A. | 2019-03-26 |
| HeartWare Ventricular Assist System (P100047/S136) | Medtronic | 2019-03-26 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S392) | Medtronic, Inc. | 2019-03-26 |