| Elecsys Anti-HCV Immunoassay (P090007/S020) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys HBsAg II (P160019/S009) | Roche Diagnostics, Inc. | 2019-04-24 |
| Ceramax Ceramic Total Hip System (P070026/S057) | DePuy Orthopaedics, Inc. | 2019-04-24 |
| Ovation iX Abdominal Stent Graft System (P120006/S032) | Endologix, LLC | 2019-04-24 |
| Elecsys Anti-HCV II (P140021/S016) | Roche Diagnostics Operations, Inc. | 2019-04-24 |
| Elecsys free PSA (P000027/S033) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HCV Immunoassay (P090009/S018) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc IgM (P110022/S027) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc IgM (P110025/S023) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HBc IgM (P110031/S024) | Roche Diagnostics Corp. | 2019-04-24 |
| LCS Total Knee System (P830055/S227) | Depuy, Inc. | 2019-04-24 |
| Elecsys HBsAg Immunoassay (P990012/S033) | Roche Diagnostics Corp. | 2019-04-24 |
| Elecsys Anti-HCV Immunoassay (P090008/S021) | Roche Diagnostics Corp. | 2019-04-24 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S081) | Dexcom, Inc. | 2019-04-24 |
| FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled (P110016/S061) | ABBOTT MEDICAL | 2019-04-23 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S044) | St Jude Medical | 2019-04-23 |
| LOTUS Edge Valve System (P180029) | Boston Scientific Corporation | 2019-04-23 |
| Straumann Emdogain (P930021/S021) | The Straumann Company | 2019-04-23 |
| PMMA Single-Piece Anterior Chamber Intraocular Lenses (P880087/S028) | Alcon Laboratories | 2019-04-22 |
| AcrySof Posterior Chamber Intraocular Lenses (P930014/S122) | Alcon Laboratories, Inc. | 2019-04-22 |
| KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System (P050027/S017) | KARL STORZ Endoscopy-America, Inc. | 2019-04-22 |
| PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S045) | Alcon Laboratories | 2019-04-22 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S090) | Alcon Research, Ltd. | 2019-04-22 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S089) | Alcon Research, Ltd. | 2019-04-22 |
| AcrySof® Posterior Chamber Intraocular Lens (P930014/S121) | Alcon Laboratories, Inc. | 2019-04-22 |
| PMMA Single-Piece Posterior Chamber Intraocular Lenses (P840060/S046) | Alcon Laboratories | 2019-04-22 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S019) | Gen-Probe Incorporated | 2019-04-22 |
| PMMA Multi-Piece Posterior Chamber Intraocular Lens (P810032/S068) | Alcon Laboratories | 2019-04-22 |
| PMMA Multi-Piece Posterior Chamber Intraocular Lenses (P810032/S069) | Alcon Laboratories | 2019-04-22 |
| PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S027) | Alcon Laboratories | 2019-04-22 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S077) | Integra Lifesciences Corp. | 2019-04-19 |
| CollaCote(TM), CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S072) | Integra Lifesciences Corp. | 2019-04-19 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S023) | Bolton Medical, Inc. | 2019-04-19 |
| ANGIO-SEAL Vascular Closure Devices (P930038/S094) | Terumo Medical Corporation | 2019-04-19 |
| ThermaCool SmartTouch SF Bi-directional and ThermoCool SmartTouch SF Uni-directional navigation Catheter (P030031/S097) | Biosense Webster, Inc. | 2019-04-19 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic- Microfibrillar Form (P810006/S085) | Integra LifeSciences Corporation | 2019-04-19 |
| ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter (P040036/S067) | Biosense Webster, Inc. | 2019-04-19 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S085) | Integra LifeSciences Corporation | 2019-04-19 |
| GORE CARDIOFORM Septal Occluder (P050006/S076) | W. L. Gore & Associates, Inc. | 2019-04-18 |
| AMS 700 Series Product Line/ Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S162) | Boston Scientific Corp | 2019-04-18 |
| Floseal NT (P990009/S053) | Baxter Healthcare Corp | 2019-04-18 |
| Melody TPV System (P140017/S014) | Medtronic, Inc. | 2019-04-18 |
| Amplatzer Septal Occluder (P000039/S066) | ABBOTT MEDICAL | 2019-04-18 |
| IntellaNav OI and IntellaNav MiFi OI Ablation Catheters (P150005/S042) | Boston Scientific Corp | 2019-04-18 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S044) | Abiomed, Inc. | 2019-04-17 |
| Oxford Partial Knee System (P010014/S085) | Biomet Manufacturing Corp | 2019-04-17 |
| CERAMAX Ceramic Total Hip System (P070026/S058) | DePuy Orthopaedics, Inc. | 2019-04-17 |
| Impella RP System (P170011/S009) | Abiomed, Inc. | 2019-04-17 |
| Oxford Partial Knee System (P010014/S084) | Biomet Manufacturing Corp | 2019-04-17 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S054) | Boston Scientific Scimed, Inc. | 2019-04-17 |
| GORE VIABAHN Endoprosthesis (P040037/S131) | W. L. Gore & Associates, Inc. | 2019-04-17 |
| Wallstent Venous Endoprosthesis with UNISTEP Plus (P980033/S053) | Boston Scientific Corporation | 2019-04-17 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S070) | W. L. Gore & Associates, Inc. | 2019-04-17 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S047) | Abiomed, Inc. | 2019-04-17 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S068) | Syncardia Systems, LLC | 2019-04-17 |
| Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S177) | Boston Scientific Corp | 2019-04-17 |
| Wallstent TIPS Endoprosthesis with UNISTEP Plus (P930031/S063) | Boston Scientific Corp | 2019-04-17 |
| Parvovirus B19 IgM Immunoassy (V619IMUS) (P970055/S019) | Diasorin | 2019-04-17 |
| Express LD Iliac Premounted Stent System (P090003/S045) | Boston Scientific Corporation | 2019-04-17 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S015) | Tiger Aesthetics Medical, LLC | 2019-04-17 |
| Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI (P980023/S091) | Biotronik, Inc. | 2019-04-16 |
| Amplia, Amplia Brava ,Brava Quad, Claria Claria Quard, Compia, Consulta, Protecta, Viva MRI XT S CRT-D (P010031/S663) | Medtronic Cardiac Rhythm Disease Management | 2019-04-16 |
| iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043/S002) | Glaukos Corporation | 2019-04-16 |
| TransPyloric Shuttle/TransPyloric Shuttle Delivery Device (P180024) | Baronova, Inc. | 2019-04-16 |
| Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters (P020025/S117) | Boston Scientific | 2019-04-16 |
| iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043/S001) | Glaukos Corporation | 2019-04-16 |
| Evera, Mirro, Primo, Protecta, Secura, Visia, S DR, VR XT DF1 MRI ICD (P980016/S703) | Medtronic Cardiac Rhythm Disease Management | 2019-04-16 |
| Consulta; Percepta Bipolar, Quadripolar; Serena Bipolar, Quadripolar; Syncra; Viva CRT-P (P010015/S401) | Medtronic, Inc. | 2019-04-16 |
| Sentus ProMRI OTW QP S-75, 85, 95, L-75, 85, 95, Sentus ProMRI OTW QP S-75/49, 85/49, 95/49, L-75/49, 85/49, 9/49 and Se (P070008/S102) | Biotronik, Inc. | 2019-04-16 |
| Micra TPS (P150033/S053) | Medtronic, Inc. | 2019-04-16 |
| Adapta, Versa, Sensia, Advisa, Astra, Attesta, Azure, Relia, Sphera, DR S XT SR MRI IPG (P980035/S585) | Medtronic, Inc. | 2019-04-16 |
| IntellaTip MiFi Xp Ablation Catheters, IntellaNsv MiFi XP Ablation Catheters and IntellaNav ST Ablation Catheters (P920047/S114) | Boston Scientific Corp | 2019-04-16 |
| PD-L1 IHC 22C3 pharmDx (P150013/S012) | Agilent Technologies, Inc. | 2019-04-16 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S106) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-04-16 |
| CareLink SmartSync Device Manager Programmer (P890003/S409) | Medtronic, Inc. | 2019-04-16 |
| Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck (P010054/S038) | Roche Diagnostics Corp. | 2019-04-15 |
| SynchroMed Infusion System, Ascenda Intrathecal SynchroMed II Clinician Programmer Application (P860004/S328) | Medtronic, Inc. | 2019-04-15 |
| Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T (P980023/S090) | Biotronik, Inc. | 2019-04-15 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Sysstems and Piseces, Specify and Vectris Spinal Cord Stimu (P840001/S426) | Medtronic Neuromodulation | 2019-04-15 |
| Visian ICL (Implantable Collamer Lens) (P030016/S036) | STAAR Surgical Company | 2019-04-15 |
| Siello S45, S53, S60 and Solia S45, S53, S60 (P950037/S199) | Biotronik, Inc. | 2019-04-15 |
| Activa Deep Brain Stimulation Therapy System (P960009/S344) | Medtronic, Inc. | 2019-04-15 |
| Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR- (P050023/S128) | Biotronik, Inc. | 2019-04-15 |
| HiResolution Bionic Ear System/AIM System (P960058/S133) | Advanced Bionics | 2019-04-12 |
| SURGICEL Absorbable Hemostats (N12159/S054) | ETHICON, Inc. | 2019-04-12 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S032) | Medinol, Ltd. | 2019-04-12 |
| Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses (P060011/S015) | Rayner Intraocular Lenses , Ltd. | 2019-04-12 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S015) | Medinol, Ltd. | 2019-04-12 |
| Optune System (P100034/S021) | Novocure, GmbH | 2019-04-12 |
| Obalon Navigation Balloon Kit (P160001/S035) | Medtimo, Inc. | 2019-04-12 |
| Biosense Webster NaviStar Thermocool Catheter (P030031/S091) | Biosense Webster, Inc. | 2019-04-12 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S031) | ETHICON, Inc. | 2019-04-12 |
| C-flex Intraocular, C-flex Aspheric Intraocular, Aspheric Intraocular and RayOne Aspheric Lens (P060011/S017) | Rayner Intraocular Lenses , Ltd. | 2019-04-12 |
| STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P990010/S008) | Amo Manufacturing USA, LLC | 2019-04-12 |
| Impella RP (P170011/S010) | Abiomed, Inc. | 2019-04-12 |
| STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P910062/S008) | Amo Manufacturing USA, LLC | 2019-04-12 |
| STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P930016/S056) | Amo Manufacturing USA, LLC | 2019-04-12 |
| therascreen FGFR RGQ RT-PCR Kit (P180043) | QIAGEN GmbH | 2019-04-12 |
| CERAMAX Ceramic Total Hip System (P070026/S056) | DePuy Orthopaedics, Inc. | 2019-04-12 |
| Electrophysiology Cable, Therapy Ablation Catheter (P040014/S036) | Irvine Biomedical, Inc. | 2019-04-11 |