| RealTime HCV (P100017/S022) | Abbott Molecular, Inc. | 2019-05-15 |
| RealTime HBV (P080026/S022) | Abbott Molecular, Inc. | 2019-05-15 |
| SURGICEL Absorbable Hemostats (N12159/S055) | ETHICON, Inc. | 2019-05-15 |
| InterStim Therapy System, Verify Evaluation System (P080025/S158) | Medtronic Neuromodulation | 2019-05-15 |
| Oxford Partial Knee System (P010014/S087) | Biomet Manufacturing Corp | 2019-05-15 |
| Activa Deep Brain Stimulation Therapy System (P960009/S303) | Medtronic, Inc. | 2019-05-15 |
| Abbott RealTime HCV GT II (P120012/S018) | Abbott Molecular | 2019-05-15 |
| HEMOBLAST Bellows (P170012/S016) | Dilon Technologies, Inc. | 2019-05-15 |
| Floseal Hemostatic Matrix (P990009/S054) | Baxter Healthcare Corp | 2019-05-15 |
| Restylane and Perlane (P040024/S110) | Q-Med AB | 2019-05-15 |
| Oxford Partial Knee System (P010014/S088) | Biomet Manufacturing Corp | 2019-05-15 |
| Abbott RealTime CMV (P160044/S002) | Abbott Molecular | 2019-05-15 |
| InterStim Therapy System, Verify Evaluation System (P970004/S263) | Medtronic Neuromodulation | 2019-05-15 |
| Artisan Myopia Intraocular Lens (P030028/S008) | Ophtec BV | 2019-05-14 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S016) | Medinol, Ltd. | 2019-05-14 |
| Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Le (P840001/S431) | Medtronic Neuromodulation | 2019-05-14 |
| GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S106) | W. L. Gore & Associates, Inc. | 2019-05-14 |
| Attain Stability Quad MRI SureScan (P080006/S132) | Medtronic, Inc. | 2019-05-14 |
| Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage (P030017/S323) | Boston Scientific Corp | 2019-05-14 |
| Cologuard (P130017/S027) | Exact Sciences Corporation | 2019-05-14 |
| Gore Excluder AAA Endoprosthesis (P020004/S165) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Gore Viatorr Tips Endoprosthesis (P040027/S073) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| CareLink Encore Programmer, CareLink Encore Programmer Head, CareLink SmartSync Device Manager Patient Connector, CareLi (P890003/S410) | Medtronic, Inc. | 2019-05-13 |
| Consulta, Syncra, and Viva CRT-P (P010015/S405) | Medtronic, Inc. | 2019-05-13 |
| Acuity X4 Liners (P010012/S503) | Boston Scientific Corp | 2019-05-13 |
| Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S132) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S071) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S592) | Medtronic, Inc. | 2019-05-13 |
| Gore Tag Thoracic Endoprosthesis (P040043/S111) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Onclarity HPV Assay (P160037/S002) | Becton, Dickinson and Company | 2019-05-13 |
| activeL Artificial Disc (P120024/S008) | Highridge Medical, LLC | 2019-05-13 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S021) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| Avalus Bioprosthesis (P170006/S011) | Medtronic, Inc. | 2019-05-13 |
| Therakos CELLEX Procedural Kit (P860003/S101) | Therakos Development Limited | 2019-05-13 |
| Gore Tigris Vascular Stent (P160004/S028) | W. L. Gore & Associates, Inc. | 2019-05-13 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S030) | ETHICON, Inc. | 2019-05-13 |
| In.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S044) | Medtronic, Inc. | 2019-05-10 |
| LCS Total Knee System - ATTUNE Revision Femoral and Tibial Sleeves (P830055/S229) | Depuy, Inc. | 2019-05-10 |
| Juvéderm Injectable Gel Implants (P050047/S070) | Allergan | 2019-05-10 |
| Freestyle Libre Flash Glucose Monitoring System; Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S033) | Abbott Diabetes Care, Inc. | 2019-05-10 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S041) | Abbott Diabetes Care, Inc. | 2019-05-10 |
| M6-C Artificial Cervical Disc (P170036/S002) | Spinal Kinetics, LLC | 2019-05-10 |
| Juvéderm Injectable Gel Implants (P110033/S045) | Allergan | 2019-05-10 |
| Cobas CMV Test (P160041/S018) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S007) | Boston Scientific Corp | 2019-05-09 |
| Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S075) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Cobas HPV Test (P100020/S046) | Roche Molecular Systems, Inc. | 2019-05-09 |
| LCS Total Knee System (P830055/S226) | Depuy, Inc. | 2019-05-09 |
| lnnova Self-Expanding Stent System (P140028/S039) | Boston Scientific Corporation | 2019-05-09 |
| LIFEPAK® 20e defibrillator/monitor (P160026/S006) | Physio-Control, Inc. | 2019-05-09 |
| Epic Vascular Self-Expanding Stent System (P110035/S049) | Boston Scientific Corp | 2019-05-09 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S046) | Roche Molecular Systems, Inc. | 2019-05-09 |
| Cobas HBV Test (P150014/S025) | Roche Molecular Systems, Inc. | 2019-05-09 |
| OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series) (P940010/S016) | Pinnacle Biologics, Inc. | 2019-05-09 |
| LCS Total Knee System (P830055/S220) | Depuy, Inc. | 2019-05-09 |
| Cobas HCV Test (P150015/S027) | Roche Molecular Systems, Inc. | 2019-05-09 |
| PathVysion HER-2 DA Probe Kit (P980024/S020) | Abbott Molecular, Inc. | 2019-05-08 |
| Artic Front Advance Cardiac CryoAblation Catheters (P100010/S092) | Medtronic Cryocath, LP | 2019-05-08 |
| CoolFlow Irrigation Tubing Set (P990071/S040) | Biosense Webster, Inc. | 2019-05-08 |
| COBAS TaqMan HBV Test for use on the High Pure System and COBAS AMpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S075) | Roche Molecular Systems, Inc. | 2019-05-08 |
| AudioKey 1.0 and AudioLink (P000025/S109) | Med-El Corp. | 2019-05-08 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S092) | CooperVision, Inc. | 2019-05-08 |
| UroVysion Bladder Cancer Kit (P030052/S025) | Abbott Molecular | 2019-05-08 |
| COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S074) | Roche Molecular Systems, Inc. | 2019-05-08 |
| methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S082) | CooperVision, Inc. | 2019-05-08 |
| Vysis CLL FISH Probe Kit (P150041/S005) | Abbott Molecular, Inc. | 2019-05-08 |
| BAUSCH + LOMB Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (P170035/S003) | Bausch and Lomb, Inc., | 2019-05-08 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S018) | Abbott Molecular, Inc. | 2019-05-08 |
| EUFLEXXA (1% Sodium Hyaluronate) (P010029/S028) | Ferring Pharmaceuticals, Inc. | 2019-05-08 |
| FineTuner Echo (P000025/S108) | Med-El Corp. | 2019-05-08 |
| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S001) | Endomagnetics Ltd., | 2019-05-08 |
| COBAS HCV TEST (P150015/S026) | Roche Molecular Systems, Inc. | 2019-05-08 |
| COBAS HPV TEST (P100020/S045) | Roche Molecular Systems, Inc. | 2019-05-08 |
| CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S075) | Integra Lifesciences Corp. | 2019-05-07 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collstat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S087) | Integra LifeSciences Corporation | 2019-05-07 |
| Pulse Geneerator, Permanent, Implantable (P950037/S201) | Biotronik, Inc. | 2019-05-07 |
| Tupos LV/ATx and Kronos LV-T CRT-D System (P050023/S131) | Biotronik, Inc. | 2019-05-07 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S088) | Integra LifeSciences Corporation | 2019-05-07 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S080) | Integra Lifesciences Corp. | 2019-05-07 |
| Barricaid Anular Closure Device (P160050/S001) | Intrinsic Therapeutics | 2019-05-07 |
| Stratos LV/LV-T CRT-P System (P070008/S103) | Biotronik, Inc. | 2019-05-07 |
| FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enable (Flex SE) (P110016/S062) | ABBOTT MEDICAL | 2019-05-07 |
| Livewire TC Ablation Catheter (Livewire TC) (P960016/S078) | St Jude Medical | 2019-05-07 |
| Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE) (P130026/S045) | St Jude Medical | 2019-05-07 |
| Integra Dermal Regeneration Template, Intergra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regener (P900033/S079) | Integra Lifesciences Corp. | 2019-05-07 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S087) | Integra LifeSciences Corporation | 2019-05-07 |
| CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S074) | Integra Lifesciences Corp. | 2019-05-07 |
| Helistat and Helitene Absorbabale Collagen Hemostatic Agents (P850010/S088) | Integra LifeSciences Corporation | 2019-05-07 |
| Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, and Sphera DR/SR MRI IPG (P980035/S588) | Medtronic, Inc. | 2019-05-06 |
| IMPELLA 5.0 System (P140003/S051) | Abiomed, Inc. | 2019-05-06 |
| Impella 5.0 (P140003/S049) | Abiomed, Inc. | 2019-05-06 |
| AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Penile Prosthesis (N970012/S157) | Boston Scientific Corp | 2019-05-06 |
| AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Penile Prosthesis (N970012/S158) | Boston Scientific Corp | 2019-05-06 |
| AMS 800 Artifical Urinary Sphinchter (P000053/S101) | Boston Scientific Corp | 2019-05-06 |
| AMS 800 Artificial Urinary Sphincter (P000053/S100) | Boston Scientific Corp | 2019-05-06 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S031) | Abbott Diabetes Care, Inc. | 2019-05-06 |
| PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody (P990081/S040) | Ventana Medical Systems, Inc. | 2019-05-06 |
| Endurant, Endurant II and Endurant IIs Stent Graft System (P100021/S076) | Medtronic Vascular | 2019-05-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S038) | Medtronic Vascular | 2019-05-05 |
| Elecsys total PSA Test System (P990056/S036) | Roche Diagnostics Corp. | 2019-05-03 |