| Perceval Heart Valve (P150011/S014) | Corcym S.r.l. | 2019-01-08 |
| Amplatzer Septal Occluder/Amplatzer Cribriform Occluder (P000039/S063) | ABBOTT MEDICAL | 2019-01-08 |
| Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Le (P840001/S417) | Medtronic Neuromodulation | 2019-01-08 |
| Amplatzer Muscular VSD Occluder (P040040/S034) | ABBOTT MEDICAL | 2019-01-08 |
| Activa Deep Brian Stimulation Therapy System (P960009/S335) | Medtronic, Inc. | 2019-01-08 |
| Restore, Itrel, Synergy and Intellis. Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Simul (P840001/S418) | Medtronic Neuromodulation | 2019-01-08 |
| Praxis (MiSeqDx) Extended RAS Panel (P160038/S007) | Illumina, Inc. | 2019-01-08 |
| LCS(R) Total Knee System (P830055/S213) | Depuy, Inc. | 2019-01-08 |
| LifeVest Wearable Defibrilator (P010030/S110) | Zoll Manufacturing Corporation | 2019-01-07 |
| Advisa DR, DR MRI and SR MRI IPG (P980035/S574) | Medtronic, Inc. | 2019-01-07 |
| Consulta CRT-P, Syncra CRT-P, and Viva CRT-P (P010015/S388) | Medtronic, Inc. | 2019-01-07 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S045) | Abiomed, Inc. | 2019-01-07 |
| Enhancements to Software Model 9986 version 2.11.1 and Model SW028 to version 8.2.1 (P890003/S401) | Medtronic, Inc. | 2019-01-07 |
| QuantiFERON - TB Gold Test, QuantiFERON - TB Gold Plus Test (P010033/S042) | Qiagen | 2019-01-04 |
| CARDIOMEMS HF SYSTEM (P100045/S007) | ABBOTT MEDICAL | 2019-01-04 |
| Bioglue Surgical Adhesive (P010003/S032) | Cryolife, Inc. | 2019-01-04 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S042) | Medtronic, Inc. | 2019-01-04 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P030054/S356) | ABBOTT MEDICAL | 2019-01-03 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P960013/S099) | ABBOTT MEDICAL | 2019-01-03 |
| GORE VIABAHN Endoprosthesis (P040037/S105) | W. L. Gore & Associates, Inc. | 2019-01-03 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S087) | Medtronic Cryocath, LP | 2019-01-03 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P140033/S034) | ABBOTT MEDICAL | 2019-01-03 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P030035/S171) | ABBOTT MEDICAL | 2019-01-03 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S044) | W. L. Gore & Associates, Inc. | 2019-01-03 |
| cobas HPV Test (P100020/S042) | Roche Molecular Systems, Inc. | 2019-01-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin BIoactive Surface (P040037/S125) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE TAG Thoracic Endoprosthesis (P040043/S108) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S069) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin BIoactive Surface (P130006/S064) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| EXCLUDER AAA Endoprosthesis (P020004/S162) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE CARDIOFORM Septal Occluder (P050006/S072) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| cobas HBV (P150014/S023) | Roche Molecular Systems, Inc. | 2019-01-02 |
| cobas CMV (P160041/S016) | Roche Molecular Systems, Inc. | 2019-01-02 |
| GORE TIGRIS Vascular Stent (P160004/S024) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test (P060030/S072) | Roche Molecular Systems, Inc. | 2019-01-02 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S044) | Roche Molecular Systems, Inc. | 2019-01-02 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test (P050028/S073) | Roche Molecular Systems, Inc. | 2019-01-02 |
| cobas HCV (P150015/S023) | Roche Molecular Systems, Inc. | 2019-01-02 |