| Restylane Refyne and Restylane Defyne Injectable Gels (P140029/S008) | Q-Med AB | 2018-06-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D. Claria MI Quad CRT-D, Compia M (P010031/S632) | Medtronic Cardiac Rhythm Disease Management | 2018-06-13 |
| EDWARDS INTUITY Valve System (P150036/S022) | Edwards Lifesciences, LLC | 2018-06-13 |
| Elecsys Anti-HCV Immunoassay (P090008/S020) | Roche Diagnostics Corp. | 2018-06-13 |
| Nucleus Auditory Brainstem Implant (P000015/S027) | Cochlear Americas | 2018-06-13 |
| Tridyne Vascular Sealant (P150016/S014) | Neomend, Inc. | 2018-06-13 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR/VR IC (P980016/S674) | Medtronic Cardiac Rhythm Disease Management | 2018-06-13 |
| Elecsys free PSA (P000027/S031) | Roche Diagnostics Corp. | 2018-06-13 |
| FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) (P110016/S057) | ABBOTT MEDICAL | 2018-06-13 |
| Elecsys HBcAg (P130015/S015) | Roche Diagnostics Operations, Inc. | 2018-06-13 |
| Elecsys Anti-HBc II (P100031/S024) | Roche Diagnostics Corp. | 2018-06-13 |
| Elecsys HBsAg II (P160019/S007) | Roche Diagnostics, Inc. | 2018-06-13 |
| Elecsys Anti-HBc IgM (P110022/S025) | Roche Diagnostics Corp. | 2018-06-13 |
| Nucleus Hybrid L24 Implant System (P130016/S032) | Cochlear Americas | 2018-06-13 |
| Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q (P070008/S093) | Biotronik, Inc. | 2018-06-13 |
| Elecsys total PSA (P990056/S033) | Roche Diagnostics Corp. | 2018-06-13 |
| Nucleus Cochlear Implant System (P970051/S173) | Cochlear Americas | 2018-06-13 |
| llesto 7 VT-T / 5 VR-T , 7 VR-T DX; Ifora 7 VR-T /5 VR-T /7 VR-T DX , 5 VR-T DX ; Itrevia 7 VT-T/ DX (GBLi), Intica 5 VR (P050023/S120) | Biotronik, Inc. | 2018-06-13 |
| Edwards Pericardial Aortic Bioprosthesis/ Edwards INSPIRIS RESILIA Aortic Valve (P150048/S011) | Edwards Lifesciences, LLC | 2018-06-13 |
| Evia DR /DR-T /SR/SR-T ;/Entovis DR /DR-T /SR /SR-T; Estella DR / DR-T/ SR /SR-T; Effecta D /S ;/ Endora 8 DR/ 8 SR; / (P950037/S191) | Biotronik, Inc. | 2018-06-13 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S074) | Dexcom, Inc. | 2018-06-13 |
| Elecsys Anti-HBs (P010054/S036) | Roche Diagnostics Corp. | 2018-06-13 |
| TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1-Piece IOLs, TECNIS Toric 1-Piece IOLs, TECNIS Toric (P980040/S090) | Johnson & Johnson Surgical Vision, Inc. | 2018-06-12 |
| Diamondback 360 Coronary Orbital Atherectomy System (P130005/S024) | Cardiovascular Systems, Inc. | 2018-06-12 |
| cobas HPV Test, 240/960 Tests (P100020/S033) | Roche Molecular Systems, Inc. | 2018-06-12 |
| AUGMENT INJECTABLE (P100006/S005) | Biomimetic Therapeutics, LLC | 2018-06-12 |
| Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT ) (P100029/S034) | ABBOTT MEDICAL | 2018-06-12 |
| Pleural Air Leak Sealant (P010047/S057) | Neomend, Inc. | 2018-06-12 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S009) | Abbott Diabetes Care, Inc. | 2018-06-12 |
| St.Jude Medical Biocor, Epic and Epic Supra Valves (P040021/S036) | ABBOTT MEDICAL | 2018-06-12 |
| Siello S 45, Siello S 53, Siello S 60, Solia S 45, Solia S 53, Solia S 60 (P950037/S189) | Biotronik, Inc. | 2018-06-12 |
| PD-L1 IHC 22C3 pharmDx (P150013/S009) | Agilent Technologies, Inc. | 2018-06-12 |
| SofLens 38 (polymacon) Visibility Tinted Contact Lens (N16895/S101) | Bausch & Lomb, Inc. | 2018-06-11 |
| CapSure Epicardial Pacing Lead (P950024/S079) | Medtronic, Inc. | 2018-06-11 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/ Quadrip (P010015/S373) | Medtronic, Inc. | 2018-06-11 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S188) | Medtronic, Inc. | 2018-06-11 |
| Y Adaptor/Extender Kit, DF-1/IS-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, Lead Adaptor, Sprint Quatro Lead, Su (P920015/S214) | Medtronic, Inc. | 2018-06-11 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra XT/ S DR MRI IPG, Astra S/XT SR MRI IPG, Attesta D (P980035/S556) | Medtronic, Inc. | 2018-06-11 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S133) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S673) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| Myocardial Pacing Lead (P120017/S013) | Medtronic, Inc. | 2018-06-11 |
| Attain StarFix Lead (P060039/S087) | Medtronic, Inc. | 2018-06-11 |
| Transvene CS/SVC Lead (P980050/S117) | Medtronic, Inc. | 2018-06-11 |
| CapSureFix MRI Lead, Revo MRI SureScan IPG (P090013/S286) | Medtronic, Inc. | 2018-06-11 |
| Attain Ability Lead, Attain Performa Lead (P080006/S122) | Medtronic, Inc. | 2018-06-11 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S159) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| ACE Header, Defibrillation Support Device (DISD), End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S149) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S391) | Medtronic, Inc. | 2018-06-11 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S101) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL (P980040/S091) | Johnson & Johnson Surgical Vision, Inc. | 2018-06-11 |
| 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/S631) | Medtronic Cardiac Rhythm Disease Management | 2018-06-11 |
| Revo MRI SureScan IPG (P090013/S285) | Medtronic, Inc. | 2018-06-08 |
| enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T) (P910056/S027) | Bausch & Lomb, Inc. | 2018-06-08 |
| Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripolar CRT-P, (P010015/S372) | Medtronic, Inc. | 2018-06-08 |
| Advisa DR IPG, Advisa DR/SR MRI IPG (P980035/S555) | Medtronic, Inc. | 2018-06-08 |
| Supartz FX, Visco-3 (P980044/S046) | Seikagaku Corp. | 2018-06-08 |
| Guardian Glucose Sensor (3) (P160007/S003) | Medtronic Minimed | 2018-06-07 |
| Guardian Glucose Sensor (3) (P150001/S044) | Medtronic Minimed | 2018-06-07 |
| EluNIR™ Ridaforolimus Eluting Coronary Stent System (P170008/S004) | Medinol, Ltd. | 2018-06-07 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S027) | Medinol, Ltd. | 2018-06-07 |
| Guardian Glucose Sensor (3) (P160017/S042) | Medtronic Minimed, Inc. | 2018-06-07 |
| Silikon 1000 Endotamponade (P950008/S014) | Alcon | 2018-06-07 |
| Impella 5.0 System (P140003/S036) | Abiomed, Inc. | 2018-06-07 |
| Onyx Liquid Embolic System (P030004/S015) | Ev3 Neurovascular | 2018-06-06 |
| Implantable System for Remodulin (P140032/S008) | Medtronic, Inc. | 2018-06-06 |
| SynchroMed Infusion System (P860004/S307) | Medtronic, Inc. | 2018-06-06 |
| Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripolar CRT-P (P010015/S371) | Medtronic, Inc. | 2018-06-05 |
| Astra XT/S DR MRI IPG, Astra S/XT SR MRI IPG, Azure S/XT DR MRI IPG, Azure S/XT SR MRI IPG (P980035/S553) | Medtronic, Inc. | 2018-06-05 |
| Evera MRI DF-1, Evera MRI ICD's; Mirro MIR DR, Mirro MIR VR ICD's; Primo MRI DR, Primo MRI VR ICD's; Visia AF MRI DF1, V (P980016/S663) | Medtronic Cardiac Rhythm Disease Management | 2018-06-05 |
| BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) (P100025/S013) | Meridian Bioscience, Inc. | 2018-06-05 |
| InterStim, Therapy System, Verify Evaluation System (SNS Urinary Lead) (P970004/S265) | Medtronic Neuromodulation | 2018-06-02 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Leads) (P080025/S160) | Medtronic Neuromodulation | 2018-06-02 |
| Activa Deep Brain Stimulation Therapy System (P960009/S309) | Medtronic, Inc. | 2018-06-02 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord (P840001/S390) | Medtronic Neuromodulation | 2018-06-02 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S008) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heaparin Bioactive Surface (P130006/S053) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| Gore Tigris Vascular Stent (P160004/S011) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems; Pisces, Specify, and Vectris Spinal Cord Stimulati (P840001/S398) | Medtronic Neuromodulation | 2018-06-01 |
| Oxford Partial Knee System (P010014/S077) | Biomet Manufacturing Corp | 2018-06-01 |
| Ventana PD-L1 (SP263) (P160046/S004) | Ventana Medical Systems, Inc. | 2018-06-01 |
| 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/S634) | Medtronic Cardiac Rhythm Disease Management | 2018-06-01 |
| Biomedics38 (polymacon) Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S060) | CooperVision, Inc. | 2018-06-01 |
| Visitag Surpoint External Processing Unit (EPU) (P030031/S086) | Biosense Webster, Inc. | 2018-06-01 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S019) | Abbott Diabetes Care, Inc. | 2018-06-01 |
| Implantable Cardioverter Defibrillator (ICD), Dynagen EL/Mini ICD, Inogen EL/Mini ICD, Origen EL ICD/Mini ICD, Autogen E (P960040/S425) | Boston Scientific | 2018-06-01 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S009) | ABBOTT MEDICAL | 2018-06-01 |
| Activa Deep Brain Stimulation Therapy System (P960009/S315) | Medtronic, Inc. | 2018-06-01 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S028) | Abbott Diabetes Care, Inc. | 2018-06-01 |
| S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-ICD (P110042/S108) | Boston Scientific Corporation | 2018-06-01 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S167) | Medtronic Neuromodulation | 2018-06-01 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heaparin Bioactive Surface (P040037/S114) | W. L. Gore & Associates, Inc. | 2018-06-01 |
| Propel, Propel mini and Propel Contour Sinus Implants (P100044/S032) | Intersect Ent. | 2018-06-01 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D), Dynagen CRT-D/X4 CRT-D, Inogen CRT-D/X4 CRT-D, Origen CRT-D/X4 (P010012/S485) | Boston Scientific Corp | 2018-06-01 |
| Obalon Balloon Kit (P160001/S017) | Medtimo, Inc. | 2018-06-01 |
| HeartMate ll Left Ventricular Assist System (LVAS) (P060040/S070) | ABBOTT MEDICAL | 2018-06-01 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S272) | Medtronic Neuromodulation | 2018-06-01 |
| cobas HPV Test (P100020/S031) | Roche Molecular Systems, Inc. | 2018-06-01 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S308) | Medtronic, Inc. | 2018-06-01 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF2 IC (P980016/S676) | Medtronic Cardiac Rhythm Disease Management | 2018-06-01 |
| Implantable System for Remodulin (P140032/S009) | Medtronic, Inc. | 2018-06-01 |