| Siello S 45, S53, S60 / Solia S 45, S53, S 60 (P950037/S178) | Biotronik, Inc. | 2017-06-23 |
| iPro2 Continuous Glucose Monitoring (CGM) System with Enlite System (P150029/S009) | Medtronic Minimed | 2017-06-23 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S006) | Abbott Diabetes Care, Inc. | 2017-06-23 |
| FC2 FEMALE CONDOM (P080002/S002) | Clear Future, Inc. | 2017-06-23 |
| Elecsys Anti-HCV II (100/200 tests) Immunoassay (P140021/S009) | Roche Diagnostics Operations, Inc. | 2017-06-23 |
| Elecsys Anti-HBc Immunoassay (P100031/S018) | Roche Diagnostics Corp. | 2017-06-23 |
| Cologuard (P130017/S019) | Exact Sciences Corporation | 2017-06-23 |
| Elecsys Anti-HBc Immunoassay (P100032/S015) | Roche Diagnostics Corp. | 2017-06-23 |
| MyCareLink and MyCareLink Smart Patient Monitor (P890003/S373) | Medtronic, Inc. | 2017-06-23 |
| Medtronic MiniMed 630G System with Enlite Sensor (P150001/S016) | Medtronic Minimed | 2017-06-23 |
| Elecsys HBeAg Immunoassay (P130015/S010) | Roche Diagnostics Operations, Inc. | 2017-06-23 |
| IN.Pact Admiral Paclitaxel-Coated Ballon Catheter (P140010/S034) | Medtronic, Inc. | 2017-06-23 |
| Star S4 IR Excimer Laser System (P930016/S052) | Amo Manufacturing USA, LLC | 2017-06-23 |
| Paradigm Real Time Revel System (P150019/S030) | Medtronic Minimed | 2017-06-23 |
| Elecsys Anti-HBc IgM Immunoassay (P110022/S021) | Roche Diagnostics Corp. | 2017-06-23 |
| Elecsys Anti-HBs Immunoassay (P010054/S030) | Roche Diagnostics Corp. | 2017-06-23 |
| Inspire II Upper Airway Stimulator (P130008/S021) | Inspire Medical Systems | 2017-06-23 |
| Elecsys Anti-HBc IgM Immunoassay (P110031/S018) | Roche Diagnostics Corp. | 2017-06-23 |
| Sapien XT Transcatheter Heart Valve (P130009/S077) | Edwards Lifesciences, LLC | 2017-06-22 |
| CapSure SP Novus/CapSure SP Z/CapSure Z Novus/Vitatron Impulse II Lead (P850089/S124) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| Y Adaptor/Extender Kit/DF-1 Connector Port Pin Plug/HV splitter/adaptor kit/Lead Adaptor/Sprint Quattro Lead/Subcutaneou (P920015/S198) | Medtronic, Inc. | 2017-06-22 |
| SpinalStim (P850007/S036) | Orthofix, Inc. | 2017-06-22 |
| CervicalStim (P030034/S010) | Orthofix, Inc. | 2017-06-22 |
| Amplia MRI/Amplia MRI Quad;Brava/Brava Quad; Claria MRI/Claria MRI Quad; Compia MRI/Compia MRI Quad; Consulta; Maximo II (P010031/S597) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| CapSureFix/CapSureFix Novus/Vitatron Crystalline Active Fixation Lead (P930039/S172) | Medtronic, Inc. | 2017-06-22 |
| CapSure Epicardial Pacing Lead (P950024/S073) | Medtronic, Inc. | 2017-06-22 |
| Biofinity XR Toric (P080011/S060) | CooperVision, Inc. | 2017-06-22 |
| Adapta, Versa, Sensia/Advisa DR/Advisa DR MRI/Advisa SR MRI/ASTRA S DR MRI/ASTRA S SR MRI/ASTRA XT DR MRI/ASTRA XT SR MR (P980035/S508) | Medtronic, Inc. | 2017-06-22 |
| Transvene CS/SVC Lead (P980050/S110) | Medtronic, Inc. | 2017-06-22 |
| Attain StarFix Lead (P060039/S078) | Medtronic, Inc. | 2017-06-22 |
| Attain Bipolar OTW/Attain OTW LV Lead; Consulta/Percepta Bipolar/Percepta Quadripolar/Serena Bipolar/Serena Quadripolar/ (P010015/S333) | Medtronic, Inc. | 2017-06-22 |
| Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Protecta/Protecta VR/Protecta XT/Secura (P980016/S636) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| CapSureFix MRI Lead/ Revo MRI SureScan IPG (P090013/S259) | Medtronic, Inc. | 2017-06-22 |
| Oncomine Dx Target Test (P160045) | Life Technologies Corporation | 2017-06-22 |
| MitraClip and MitraClip NT Clip Delivery System (P100009/S024) | ABBOTT MEDICAL | 2017-06-22 |
| CapSure Sense/CapSure SP/CapSure SP Novus/CapSureSense/Vitatron Crystalline Lead (P830061/S146) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| Sapien 3 Transcatheter Heart Valve (P140031/S043) | Edwards Lifesciences, LLC | 2017-06-22 |
| Epicardial Patch Lead/Upsizing Sleeve (P900061/S146) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| Myocardial Pacing Lead (P120017/S008) | Medtronic, Inc. | 2017-06-22 |
| Attain Ability/Performa Lead (P080006/S109) | Medtronic, Inc. | 2017-06-22 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S067) | Medtronic Sofamor Danek USA, Inc. | 2017-06-21 |
| HeartWare Ventricular Assist System (P100047/S094) | Medtronic | 2017-06-21 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S364) | Medtronic Neuromodulation | 2017-06-21 |
| Implantable Cardioverter Defibrillator (ICD) - Origen: D000, D001, D002, D003, D050, D051, D052, D053 - Inogen: D010, D0 (P960040/S394) | Boston Scientific | 2017-06-21 |
| Precision Spectra Spinal Cord Stimulator (SCS) System (P030017/S294) | Boston Scientific Corp | 2017-06-21 |
| Activa Deep Brain Stimulation Therapy System (P960009/S283) | Medtronic, Inc. | 2017-06-21 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) - Origne: G050, G051, G056, G058 - Inogen: G140, G141, G146, G14 (P010012/S451) | Boston Scientific Corp | 2017-06-21 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S002) | Medtronic Vascular | 2017-06-21 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S079) | Medtronic Vascular | 2017-06-21 |
| Spinal Cord Stimulator External Pulse Generator (P010032/S128) | ABBOTT MEDICAL | 2017-06-21 |
| Stockert 70 RF Generator Foot Pedal (P990071/S035) | Biosense Webster, Inc. | 2017-06-21 |
| Precision Montage and Precision Montage MRI Spinal Cord Stimulator System (P030017/S293) | Boston Scientific Corp | 2017-06-21 |
| Infuse Bone Graft (P000054/S048) | Medtronic Sofamor Danek USA, Inc. | 2017-06-21 |
| Perimount Aortic and Mitral Bioprostheses (P860057/S163) | Edwards Lifesciences, LLC | 2017-06-20 |
| Quantiferon TB Gold (P010033/S034) | Qiagen | 2017-06-20 |
| VISTAKON (senofilcon A) ACUVUE OASYS® Brand Contact Lenses. (P040045/S076) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-06-20 |
| Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Compia (P010031/S595) | Medtronic Cardiac Rhythm Disease Management | 2017-06-20 |
| Sapien XT Transcatheter Heart Valve (P130009/S076) | Edwards Lifesciences, LLC | 2017-06-20 |
| EDWARDS INTUITY VALVE SYSTEM (P150036/S002) | Edwards Lifesciences, LLC | 2017-06-20 |
| HeartWare Ventricular Assist System (P100047/S093) | Medtronic | 2017-06-20 |
| CVX-300 and CVX-300P Excimer Laser Systems (P910001/S093) | Spectranetics Corp. | 2017-06-20 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESES/ THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX T (P860057/S156) | Edwards Lifesciences, LLC | 2017-06-20 |
| Sapien S3 Transcatheter Heart Valve (P140031/S042) | Edwards Lifesciences, LLC | 2017-06-20 |
| ACTIVL ARTIFICIAL DISC (P120024/S004) | Highridge Medical, LLC | 2017-06-20 |
| Evera MRI DF-1 ICD, Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR/ S VR/ XT DR/ XT VR ICD's ; Maximo II ICD; Pritectai I (P980016/S634) | Medtronic Cardiac Rhythm Disease Management | 2017-06-20 |
| Senofilcon A Reactive Monomer Mix (RMM) Batches (P040045/S074) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-06-20 |
| Impella CP Ventricular Support System (P140003/S019) | Abiomed, Inc. | 2017-06-20 |
| Intuity Elite Valve System (P150036/S012) | Edwards Lifesciences, LLC | 2017-06-20 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S057) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025 (P860008/S023) | Cardio Command | 2017-06-19 |
| GORE TIGRIS Vascular Stent (P160004/S004) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S002) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE TAG Thoracic Endoprosthesis (P040043/S093) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| Precision Spectra and Spectra WaveWriter Spinal Cord Stimulator (P030017/S292) | Boston Scientific Corp | 2017-06-19 |
| GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S038) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S144) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S099) | W. L. Gore & Associates, Inc. | 2017-06-19 |
| Innova Vascular Self-Expanding Stent System (P140028/S027) | Boston Scientific Corporation | 2017-06-16 |
| Visian Implantable Collamer Lens for Myopia (P030016/S031) | STAAR Surgical Company | 2017-06-16 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S073) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-06-16 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S036) | Beckman Coulter, Inc. | 2017-06-16 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S075) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-06-16 |
| Edwards Commander Delivery System (P140031/S044) | Edwards Lifesciences, LLC | 2017-06-16 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S033) | Beckman Coulter, Inc. | 2017-06-16 |
| Ambicor Implantable Penile Prosthesis (N970012/S135) | Boston Scientific Corp | 2017-06-16 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S018) | Beckman Coulter, Inc. | 2017-06-16 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S143) | W. L. Gore & Associates, Inc. | 2017-06-16 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S092) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-06-16 |
| GORE CARDIOFORM Septal Occluder (P050006/S059) | W. L. Gore & Associates, Inc. | 2017-06-16 |
| Collamer, UV-Absorbing Posterior Chamber Intraocular Lens (P990013/S035) | Starr Surgical Co. | 2017-06-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S045) | Beckman Coulter, Inc. | 2017-06-16 |
| GORE TAG Thoracic Endoprosthesis (P040043/S092) | W. L. Gore & Associates, Inc. | 2017-06-16 |
| Epic Vascular Self-Expanding Stent System (P110035/S041) | Boston Scientific Corp | 2017-06-16 |
| InterStim Therapy System, Verify Evaluation System (Urinary) (P970004/S245) | Medtronic Neuromodulation | 2017-06-15 |
| G4 Insulin Pump with Dexcom G4 Platinum CGM System (P140015/S022) | Tandem Diabetes Care, Inc. | 2017-06-15 |
| Interstim Therapy System, Verify Evaluation System (SNS) Bowel (P080025/S140) | Medtronic Neuromodulation | 2017-06-15 |
| Activa Deep Brain Stimualtion Therapy System (DBS) (P960009/S282) | Medtronic, Inc. | 2017-06-15 |
| CardioMEMS HF System (P100045/S017) | ABBOTT MEDICAL | 2017-06-15 |
| AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESIS (N970012/S114) | Boston Scientific Corp | 2017-06-15 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S025) | Cook Ireland, Ltd. | 2017-06-15 |