| Elecsys HBeAg and PreciControl HBeAg (P130015/S011) | Roche Diagnostics Operations, Inc. | 2017-08-16 |
| Elecsys Anti-HBC Immunoassay test system (P100032/S014) | Roche Diagnostics Corp. | 2017-08-16 |
| Activa Deep Brain Stimulation Therapy System (P960009/S285) | Medtronic, Inc. | 2017-08-16 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S011) | Medtronic Minimed | 2017-08-16 |
| Azure XT SR / DR MRI SureScan, Azure S SR / S DR MRI SureScan , Software Model (P980035/S506) | Medtronic, Inc. | 2017-08-16 |
| CapSureFix MRI Lead (P090013/S262) | Medtronic, Inc. | 2017-08-16 |
| SelectSecure MRI SureScan Lead (P030036/S095) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| PARADIGM REAL-TIME REVEL SYSTEM ENLITE SENSOR (P150019/S031) | Medtronic Minimed | 2017-08-16 |
| MINIMED 530G SYSTEM ENLITE SENSOR (P120010/S105) | Medtronic, Inc. | 2017-08-16 |
| Y Adaptor/Extender Kit/Sprint Quattro Lead/Subcutaneous Lead (P920015/S201) | Medtronic, Inc. | 2017-08-16 |
| SynchroMed Infusion System (P860004/S286) | Medtronic, Inc. | 2017-08-16 |
| Nucleus Hybrid Cochlear Implant System (P130016/S031) | Cochlear Americas | 2017-08-16 |
| Attain OTW LV Lead (P010015/S342) | Medtronic, Inc. | 2017-08-16 |
| CapSureFix Lead/CapSureFix Novus Lead/Vitatron Crystalline Active Fixation Lead (P930039/S175) | Medtronic, Inc. | 2017-08-16 |
| CapSure Sense MRI SureScan Lead (P830061/S145) | Medtronic, Inc. | 2017-08-16 |
| CapSure Epicardial Pacing Lead (P950024/S075) | Medtronic, Inc. | 2017-08-16 |
| CapSure SP Novus Lead/CapSure SP Z Lead/CapSure Z Novus Lead/Vitatron Impulse II Lead (P850089/S127) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| InterStim Therapy System (SNS Urinary Programming Systems) (P970004/S248) | Medtronic Neuromodulation | 2017-08-16 |
| Attain Ability Lead (P080006/S113) | Medtronic, Inc. | 2017-08-16 |
| SelectSecure Lead (P030036/S096) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| Edora 8 HF-T QP, Edora 8 HF-T/QP, Evity 8 HF-T/QP,Evity 8 HF-T/QP, Corox (ProMRI) OTW 85 BP, L85 BP, S 85 BP, Sentus (Pr (P070008/S084) | Biotronik, Inc. | 2017-08-16 |
| Myocardial Pacing Lead (P120017/S010) | Medtronic, Inc. | 2017-08-16 |
| Device Command Library (DCL), CareLine Express (P890003/S374) | Medtronic, Inc. | 2017-08-16 |
| CapSure VDD 2 Lead/Vitatron Brilliant S+ VDD Lead (P890003/S379) | Medtronic, Inc. | 2017-08-16 |
| SQ-RX, Emblem, Emblem MRI S-ICD (P110042/S089) | Boston Scientific Corporation | 2017-08-16 |
| CapSureFix MRI SureScan Lead (P090013/S256) | Medtronic, Inc. | 2017-08-16 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S366) | Medtronic Neuromodulation | 2017-08-16 |
| Edwards Crimper model 9600CR (P140031/S041) | Edwards Lifesciences, LLC | 2017-08-15 |
| cobas KRAS Mutation Test (P140023/S010) | Roche Molecular Systems, Inc. | 2017-08-15 |
| cobas HPV Test (P100020/S024) | Roche Molecular Systems, Inc. | 2017-08-15 |
| Sapien 3 - Transcatheter Heart Valve and Accessories (P140031/S051) | Edwards Lifesciences, LLC | 2017-08-15 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S004) | W. L. Gore & Associates, Inc. | 2017-08-15 |
| cobas 4800 BRAF V600 Mutation Test (P110020/S021) | Roche Molecular Systems, Inc. | 2017-08-15 |
| cobas EGFR Mutation Test v2 (P120019/S014) | Roche | 2017-08-15 |
| NeuroPace RNS System (P100026/S047) | NeuroPace, Inc. | 2017-08-14 |
| Codman 3000 Refill Kit (P890055/S067) | Intera Oncology | 2017-08-14 |
| Endurity, Endurity Core, Assurity, Assurity+ (P880086/S285) | ABBOTT MEDICAL | 2017-08-14 |
| Endurity MRI, Assurity MRI (P140033/S011) | ABBOTT MEDICAL | 2017-08-14 |
| Adapta, Versa, Sensia IPGs ADSR01, ADDR01, ADDR06, ADDRL1, ADDRS1, VEDR01, ADD01, SEDRL1, SED01, SES01, ADDR03, SEDR01, (P980035/S516) | Medtronic, Inc. | 2017-08-14 |
| Oncomine Dx Target Test (P160045/S001) | Life Technologies Corporation | 2017-08-14 |
| Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S074) | CooperVision, Inc. | 2017-08-14 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S078) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-08-11 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S137) | Boston Scientific Corp | 2017-08-11 |
| COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S031) | Roche Molecular Systems, Inc. | 2017-08-11 |
| iPro2 Continuous Glucose Monitoring (CGM) System (P980022/S200) | Medtronic Minimed | 2017-08-11 |
| COBAS TAQMAN HBV TEST (P050028/S057) | Roche Molecular Systems, Inc. | 2017-08-11 |
| VNS Therapy System (P970003/S213) | LivaNova USA, Inc. | 2017-08-11 |
| PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems (P030017/S275) | Boston Scientific Corp | 2017-08-11 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S064) | Dexcom, Inc. | 2017-08-11 |
| SofLens (polymacon) Visibility Tinted Contact Lens (N16895/S100) | Bausch & Lomb, Inc. | 2017-08-11 |
| COBAS HPV TEST (P100020/S023) | Roche Molecular Systems, Inc. | 2017-08-11 |
| iPro2 Professional Continuous Glucose Monitoring (CGM) System (P150029/S010) | Medtronic Minimed | 2017-08-11 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S020) | Roche Molecular Systems, Inc. | 2017-08-11 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S058) | Roche Molecular Systems, Inc. | 2017-08-11 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S514) | Medtronic, Inc. | 2017-08-10 |
| BIOSENSE WEBSTER CABLES (P990071/S034) | Biosense Webster, Inc. | 2017-08-10 |
| Endurant, EndurantII, Endurant lls Stent Graft Systems (P100021/S065) | Medtronic Vascular | 2017-08-10 |
| Tryton Side Branch Stent (P150039/S002) | Poseidon Medical, Inc. | 2017-08-10 |
| NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S049) | Biosense Webster, Inc. | 2017-08-10 |
| BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S074) | Biosense Webster, Inc. | 2017-08-10 |
| Valiant Thoracic Stent Graft System (P100040/S032) | Medtronic Vascular | 2017-08-10 |
| NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P040036/S055) | Biosense Webster, Inc. | 2017-08-10 |
| NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER (P010068/S051) | Biosense Webster, Inc. | 2017-08-10 |
| WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER (P950005/S061) | Biosense Webster, Inc. | 2017-08-10 |
| Elecsys Anti-HCV II Test System (P140021/S008) | Roche Diagnostics Operations, Inc. | 2017-08-10 |
| St. Jude Medical Mechanical heart Valves (P810002/S103) | ABBOTT MEDICAL | 2017-08-10 |
| Gore Tigris Vascular Stent (P160004/S005) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| Hancock Modified Orifice (MO) Valved Conduit, Model 150 (P790007/S051) | Medtronic Heart Valves | 2017-08-09 |
| Gore Viabahn Endoprosthesis (P040037/S100) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S015) | Nevro Corporation | 2017-08-09 |
| Mosaic Bioprosthesis, Models 305 and 310 (P990064/S069) | Medtronic, Inc. | 2017-08-09 |
| cobas HBV Test (P150014/S008) | Roche Molecular Systems, Inc. | 2017-08-09 |
| GoreViabahn VBX Balloon Expandable Endoprosthesis (P160021/S003) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| Hancock II Bioprosthesis, Models T505 and T510 (P980043/S061) | Medtronic, Inc. | 2017-08-09 |
| cobas KRAS Mutation Test (P140023/S009) | Roche Molecular Systems, Inc. | 2017-08-09 |
| Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S039) | W. L. Gore & Associates, Inc. | 2017-08-09 |
| COBAS TaqMan HCV Test, v2.0, for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S057) | Roche Molecular Systems, Inc. | 2017-08-09 |
| cobas HPV Test (P100020/S022) | Roche Molecular Systems, Inc. | 2017-08-09 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S013) | Roche | 2017-08-09 |
| Spectrum Saline Breast Implants (P990075/S042) | Mentor Worldwide, LLC | 2017-08-09 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S030) | Roche Molecular Systems, Inc. | 2017-08-09 |
| cobas HCV Test (P150015/S007) | Roche Molecular Systems, Inc. | 2017-08-09 |
| CT LUCIA 202 IOL and CT LUCIA 602 IOL (P100016/S004) | Carl Zeiss Meditec Production, LLC | 2017-08-09 |
| Restylane Injectable Gels (P040024/S098) | Q-Med AB | 2017-08-09 |
| COBAS TaqMan HBV Test for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S056) | Roche Molecular Systems, Inc. | 2017-08-09 |
| cobas BRAF V600 Mutation Test (P110020/S019) | Roche Molecular Systems, Inc. | 2017-08-09 |
| Freestyle Bioprosthesis, Model 995, 995SC and 995MS (P970031/S057) | Medtronic, Inc. | 2017-08-09 |
| Hancock Valved Conduit, Model 105 (P870078/S036) | Medtronic, Inc. | 2017-08-09 |
| cobas CMV Test (P160041/S001) | Roche Molecular Systems, Inc. | 2017-08-09 |
| InterStim Therapy System, Verify Evalution System (P080025/S145) | Medtronic Neuromodulation | 2017-08-08 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S285) | Medtronic, Inc. | 2017-08-08 |
| Terminal Pin Weld Process Monitoring Plan (P010012/S457) | Boston Scientific Corp | 2017-08-08 |
| Cologuard (P130017/S020) | Exact Sciences Corporation | 2017-08-08 |
| Emblem Subcutaneous Implantable Cardioverter Defibrillator Pulse Gerator (P110042/S087) | Boston Scientific Corporation | 2017-08-08 |
| Activa Deep Brain Stimulation Therapy System (P960009/S287) | Medtronic, Inc. | 2017-08-08 |
| Restore Itrel and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads. (P840001/S368) | Medtronic Neuromodulation | 2017-08-08 |
| InterStim Therapy System, Verify Evalution System (P970004/S250) | Medtronic Neuromodulation | 2017-08-08 |
| EXOSEAL Vascular Closure Device (P100013/S014) | Cordis US Corporation | 2017-08-07 |
| NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re (P960040/S400) | Boston Scientific | 2017-08-07 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System (P160043/S004) | Medtronic Vascular | 2017-08-07 |