| SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System (P030011/S062) | Syncardia Systems, LLC | 2018-07-04 |
| FreeStyle Libre Flash Glucose Monitoring System (P160030/S023) | Abbott Diabetes Care, Inc. | 2018-07-03 |
| Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit (P140023/S014) | Roche Molecular Systems, Inc. | 2018-07-03 |
| G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System (P120005/S073) | Dexcom, Inc. | 2018-07-03 |
| COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit (P060030/S065) | Roche Molecular Systems, Inc. | 2018-07-03 |
| AFX Endovascular AAA System (P040002/S060) | Endologix, LLC | 2018-07-03 |
| PROGEL Pleural Air Leak Sealant (PALS) (P010047/S046) | Neomend, Inc. | 2018-07-03 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S031) | Abbott Diabetes Care, Inc. | 2018-07-03 |
| InterStim Therapy System, Verify Evaluation System (P080025/S163) | Medtronic Neuromodulation | 2018-07-03 |
| Oxford Partial Knee System (P010014/S071) | Biomet Manufacturing Corp | 2018-07-03 |
| cobas HBV Test (P150014/S016) | Roche Molecular Systems, Inc. | 2018-07-03 |
| cobas HCV Test (P150015/S015) | Roche Molecular Systems, Inc. | 2018-07-03 |
| COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit (P050028/S066) | Roche Molecular Systems, Inc. | 2018-07-03 |
| Master InterStim Therapy System, Verify Evaluation System (P970004/S268) | Medtronic Neuromodulation | 2018-07-03 |
| cobas HPV Test, 240/960 Tests (P100020/S034) | Roche Molecular Systems, Inc. | 2018-07-03 |
| Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test (P110020/S025) | Roche Molecular Systems, Inc. | 2018-07-03 |
| cobas CMV Test for use on the cobas 6800/8800 System (P160041/S009) | Roche Molecular Systems, Inc. | 2018-07-03 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S063) | Integra Lifesciences Corp. | 2018-07-03 |
| COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S037) | Roche Molecular Systems, Inc. | 2018-07-03 |
| Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit (P120019/S021) | Roche | 2018-07-03 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S063) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S032) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S015) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S032) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| Cartiva SCI (P150017/S009) | Cartiva, Inc. | 2018-07-02 |
| GORE TAG Thoracic Endoprosthesis (P040043/S101) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025) | Ortho-Clinical Diagnostics | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026) | Ortho-Clinical Diagnostics | 2018-07-02 |
| ROTAPRO Rotational Atherectomy System (P900056/S171) | Boston Scientific Corp | 2018-07-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S116) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S038) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S030) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S013) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S012) | Ortho-Clinical Diagnostics | 2018-07-02 |
| MiniMed 670G System Pump (P160017/S043) | Medtronic Minimed, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S034) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026) | Physio-Control, Inc. | 2018-07-02 |
| MiniMed 630G Insulin Pump (P150001/S045) | Medtronic Minimed | 2018-07-02 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S076) | CooperVision, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S037) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| Cartiva SCI Implant (P150017/S008) | Cartiva, Inc. | 2018-07-02 |
| VENTANA PD-L1(SP142) CDX ASSAY (P160002/S006) | Ventana Medical Systems, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S033) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| GORE TIGRIS Vascular Stent (P160004/S013) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S055) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S154) | W. L. Gore & Associates, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S014) | Ortho-Clinical Diagnostics | 2018-07-02 |
| CoreValve System, CoreValve Evolut R System, CoreValve Evolut PRO System (P130021/S050) | Medtronic, Inc. | 2018-07-02 |
| cobas HPV Test, 240 Tests (P100020/S025) | Roche Molecular Systems, Inc. | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S029) | Ortho-Clinical Diagnostics, Inc. | 2018-07-02 |
| Hancock II Bioprosthesis (P980043/S067) | Medtronic, Inc. | 2018-06-29 |
| tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (N17679/S040) | CooperVision, Inc. | 2018-06-29 |
| Hancock Valved Conduit (P870078/S042) | Medtronic, Inc. | 2018-06-29 |
| methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S079) | CooperVision, Inc. | 2018-06-29 |
| Ascension MCP (P000057/S010) | Smith & Nephew, Inc. | 2018-06-29 |
| CVX-300-P Excimer Laser System (P910001/S097) | Spectranetics Corp. | 2018-06-29 |
| Zephyr Endobronchial Valve System (P180002) | Pulmonx Corporation | 2018-06-29 |
| Hancock Modified Orifice Valved Conduit (P790007/S057) | Medtronic Heart Valves | 2018-06-29 |
| MitraClip Clip Delivery System (NTR and XTR) (P100009/S027) | ABBOTT MEDICAL | 2018-06-29 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S020) | Abbott Diabetes Care, Inc. | 2018-06-28 |
| Guardian Connect System (P160007/S006) | Medtronic Minimed | 2018-06-28 |
| Percepta Quad CRT-P MRI SureScan, Percepta CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, Serena CRT-P MRI SureScan (P010015/S368) | Medtronic, Inc. | 2018-06-28 |
| ETI-AB-AUK PLUS Assay (P990042/S024) | DiaSorin, Inc. | 2018-06-28 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S374) | Medtronic, Inc. | 2018-06-28 |
| Revo MRI SureScan and CapSureFix MRI SureScan Lead (P090013/S281) | Medtronic, Inc. | 2018-06-28 |
| MiniMed 670G System (P160017/S044) | Medtronic Minimed, Inc. | 2018-06-28 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form (P810006/S079) | Integra LifeSciences Corporation | 2018-06-28 |
| Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S078) | Integra LifeSciences Corporation | 2018-06-28 |
| MiniMed 530G System (P120010/S117) | Medtronic, Inc. | 2018-06-28 |
| Attain Ability MRI SureScan Lead/Ability Plus MRI SureScan Lead and Attain Ability Straight MRI SureScan Lead and Attain (P080006/S121) | Medtronic, Inc. | 2018-06-28 |
| ETI-EBK PLUS Assay (P990043/S028) | DiaSorin, Inc. | 2018-06-28 |
| Propel Contour Sinus Implant (P100044/S033) | Intersect Ent. | 2018-06-28 |
| CapSureFix Novus MRi SureScan Lead and CapSureFix Novus MRI SureScan Lead (P930039/S186) | Medtronic, Inc. | 2018-06-28 |
| Lutonix Drug Coated Ballon (P130024/S023) | Lutonix | 2018-06-28 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S029) | Abbott Diabetes Care, Inc. | 2018-06-28 |
| Attain StarFix Lead (P060039/S088) | Medtronic, Inc. | 2018-06-28 |
| Paradigm Real-Time Revel System (P150019/S043) | Medtronic Minimed | 2018-06-28 |
| IS-1 Plug, Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScan and Sprint Quattro MRI SureScan (P920015/S213) | Medtronic, Inc. | 2018-06-28 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S099) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-06-28 |
| Epic Vascular Self-Expanding Stent System (P110035/S046) | Boston Scientific Corp | 2018-06-28 |
| RESTYLANE REFYNE and RESTYLANE DEFYNE (P140029/S012) | Q-Med AB | 2018-06-28 |
| Lutonix Drug Coated Balloon (P170003/S003) | Lutonix | 2018-06-28 |
| ETI-CORE-IGMK PLUS Assay (P990044/S025) | DiaSorin, Inc. | 2018-06-28 |
| Vitatron Crystalline Active Fixation Lead and Vitatron Pirouet Lead (P930039/S189) | Medtronic, Inc. | 2018-06-28 |
| Ideal Implant Structured Breast Implant (P120011/S011) | Bimini Health Tech | 2018-06-28 |
| CapSure Sense MRI SureScan Lead and CapSure Sense MRI SureScan Lead (P830061/S157) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| SLS II/GlideLight catheters (P960042/S062) | Spectranetics (Philips) | 2018-06-28 |
| MiniMed iPro2 CGM System with Enlite Sensor (P150029/S019) | Medtronic Minimed | 2018-06-28 |
| RF Contactr, RF Conductr and RF Marinr (P930029/S060) | Medtronic, Inc. | 2018-06-28 |
| ETI-AB-EBK PLUS Assay (P990041/S027) | DiaSorin, Inc. | 2018-06-28 |
| Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVC Lead (P920015/S215) | Medtronic, Inc. | 2018-06-28 |
| Attain Ability Lead and Attain Performa Lead (P080006/S123) | Medtronic, Inc. | 2018-06-28 |
| H.E.L.P. Futura Apheresis System (P940016/S025) | B. Braun Avitum AG | 2018-06-28 |
| SelectSecure MRI SureScan Lead (P030036/S100) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S040) | Boston Scientific Corporation | 2018-06-28 |
| ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays (P990038/S028) | DiaSorin, Inc. | 2018-06-28 |
| Vitatron Brilliant S+ VDD Lead (P890003/S392) | Medtronic, Inc. | 2018-06-28 |
| Vitatron Excellence SS+ Lead (P850089/S134) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| ETI-AB-COREK PLUS Assay (P990045/S025) | DiaSorin, Inc. | 2018-06-28 |
| VISCOAT/DUOVISC Ophthalmic Viscoelastic System (P840064/S069) | Alcon Laboratories | 2018-06-28 |