| CapSure Sense MRI SureScan Lead (P830061/S168) | Medtronic Cardiac Rhythm Disease Management | 2019-05-30 |
| Express LD Iliac Premounted Stent System (P090003/S046) | Boston Scientific Corporation | 2019-05-30 |
| Attain Ability MRI SureScan Lead, Attain Ability Plus MRI SureScan Lead, Attain Ability Straight MRI SureScan Lead, Atta (P080006/S133) | Medtronic, Inc. | 2019-05-30 |
| Maestro Ablation Connection Box, IntellaNav XP and IntellaNav MiFi XP (P150005/S043) | Boston Scientific Corp | 2019-05-29 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Biopolar CRT-P and Serena Quadripolar (P010015/S406) | Medtronic, Inc. | 2019-05-29 |
| Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG, and Azure XT DR/SR MRI IPG (P980035/S593) | Medtronic, Inc. | 2019-05-29 |
| SelectSecure Lead (P030036/S109) | Medtronic Cardiac Rhythm Disease Management | 2019-05-29 |
| OBALON BALLOON SYSTEM (P160001/S038) | Medtimo, Inc. | 2019-05-29 |
| Maestro Ablation Connection Box, IntellaNav OI (P020025/S118) | Boston Scientific | 2019-05-29 |
| Vistakon (etafilcon A) Brand Contact Lenses (N18033/S104) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2019-05-29 |
| Arctic Front Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters (P100010/S090) | Medtronic Cryocath, LP | 2019-05-29 |
| Tendril MRI Steroid Eluting Cardiac Leads (P140033/S045) | ABBOTT MEDICAL | 2019-05-29 |
| Achromatizing ReSTOR 2.5 Intraocular Lenses (IOLs) (P040020/S088) | Alcon Research, Ltd. | 2019-05-28 |
| iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems (P930016/S059) | Amo Manufacturing USA, LLC | 2019-05-28 |
| GORE Cardioform ASD Occluder (P050006/S071) | W. L. Gore & Associates, Inc. | 2019-05-28 |
| Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses (P050031/S003) | CooperVision, Inc. | 2019-05-28 |
| Cobas HBV Test (P150014/S026) | Roche Molecular Systems, Inc. | 2019-05-24 |
| Manta Vascular Closure Device (P180025/S001) | Teleflex Medical, LLC | 2019-05-24 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S434) | Medtronic Neuromodulation | 2019-05-24 |
| Activa Deep Brain Stimulation Therapy System (P960009/S348) | Medtronic, Inc. | 2019-05-24 |
| therascreen PIK3CA RGQ PCR Kit (P190004) | QIAGEN GmbH | 2019-05-24 |
| NeuroPace RNS System (P100026/S068) | NeuroPace, Inc. | 2019-05-24 |
| Cobas HCV Test (P150015/S029) | Roche Molecular Systems, Inc. | 2019-05-24 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S331) | Medtronic, Inc. | 2019-05-24 |
| therascreen PIK3CA RGQ PCR Kit (P190001) | QIAGEN GmbH | 2019-05-24 |
| Implantable System for Remodulin (P140032/S033) | Medtronic, Inc. | 2019-05-24 |
| Phylax ICD System (P980023/S092) | Biotronik, Inc. | 2019-05-24 |
| Cobas CMV (P160041/S020) | Roche Molecular Systems, Inc. | 2019-05-24 |
| SNS Bowel: InterStim Therapy System and Verify Evaluation System (P080025/S184) | Medtronic Neuromodulation | 2019-05-24 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S022) | W. L. Gore & Associates, Inc. | 2019-05-24 |
| SNS Urinary: InterStim Therapy System and Verify Evaluation System (P970004/S289) | Medtronic Neuromodulation | 2019-05-24 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S068) | Boston Scientific | 2019-05-23 |
| Prostar XL Percutaneous Vascular Surgical System (P960043/S104) | Abbott Vascular, Inc. | 2019-05-23 |
| Angio-Seal Vascular Closure Devices (P930038/S095) | Terumo Medical Corporation | 2019-05-23 |
| Visi-Pro Balloon-Expandable Peripheral Stent System (P030045/S005) | Medtronic Vascular, Inc. | 2019-05-23 |
| VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P (P030005/S180) | Guidant Corp. | 2019-05-23 |
| Ingevity Leads (P150012/S077) | Boston Scientific | 2019-05-23 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P170003/S006) | Lutonix | 2019-05-23 |
| Propel, Propel Mini and Propel Contour Sinus Implants (P100044/S039) | Intersect Ent. | 2019-05-23 |
| Protege RX Carotid Stent Systems and Protege GPS Peripheral Stent Systems (P060001/S027) | Medtronic Vascular, Inc. | 2019-05-23 |
| SNS Bowel InterStim Therapy System and Verify Evaluation System (P080025/S183) | Medtronic Neuromodulation | 2019-05-23 |
| AMPLATZER PFO Occluder (P120021/S008) | ABBOTT MEDICAL | 2019-05-23 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S433) | Medtronic Neuromodulation | 2019-05-23 |
| SURGICEL SNoW Absorbable Hemostat (N12159/S053) | ETHICON, Inc. | 2019-05-23 |
| EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding peripheral Stent with Entrust Delivery Syst (P110023/S026) | Medtronic Vascular, Inc. | 2019-05-23 |
| In.Pact Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Chatheter (P140010/S045) | Medtronic, Inc. | 2019-05-23 |
| Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl (P150005/S046) | Boston Scientific Corp | 2019-05-23 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S027) | Lutonix | 2019-05-23 |
| SNS Urinary interStim Therapy System and Verify Evaluation System (P970004/S288) | Medtronic Neuromodulation | 2019-05-23 |
| StarClose SE Vascular Closure System (P050007/S038) | Abbott Vascular Devices | 2019-05-23 |
| cobas HPV Test (P100020/S047) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas BRAF v600 Muttaion Test (P110020/S032) | Roche Molecular Systems, Inc. | 2019-05-22 |
| COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S076) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas KRAS Mutation Test (P140023/S020) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas HBV (P150014/S027) | Roche Molecular Systems, Inc. | 2019-05-22 |
| COBAS TaqMan HCV Test, v2.0, for use with the High Pure System and COBAS AMpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S076) | Roche Molecular Systems, Inc. | 2019-05-22 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S108) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-05-22 |
| LIPOSORBER LA-15 System (P910018/S026) | Kaneka Pharma America Corp. | 2019-05-22 |
| cobas HCV (P150015/S028) | Roche Molecular Systems, Inc. | 2019-05-22 |
| Pipeline Flex Embolization Device (P100018/S020) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-05-22 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S234) | Boston Scientific Corp | 2019-05-22 |
| Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S026) | B. Braun Avitum AG | 2019-05-22 |
| COBAS® AmliPrep/COBAS® TaqMan® CMV Test (P110037/S047) | Roche Molecular Systems, Inc. | 2019-05-22 |
| cobas CMV (P160041/S019) | Roche Molecular Systems, Inc. | 2019-05-22 |
| COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0 (P120019/S028) | Roche | 2019-05-22 |
| VNS Therapy System (P970003/S224) | LivaNova USA, Inc. | 2019-05-22 |
| Impella RP (P170011/S011) | Abiomed, Inc. | 2019-05-21 |
| EMBLEM Programmer (P110042/S123) | Boston Scientific Corporation | 2019-05-21 |
| Aptima HCV Quant Dx Assay (P160023/S013) | Hologic, Inc. | 2019-05-21 |
| Optimizer Smart System (IPG) (P180036/S001) | Impulse Dynamics (Usa), Inc. | 2019-05-21 |
| Aptima HBV Quant Assay (P170025/S012) | Hologic, Inc. | 2019-05-21 |
| Spiration Valve System (P180007/S003) | Gyrus Acmi, Inc. | 2019-05-21 |
| Hemoblast Bellows (P170012/S017) | Dilon Technologies, Inc. | 2019-05-21 |
| Oncomine Dx Target Test (P160045/S015) | Life Technologies Corporation | 2019-05-21 |
| Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S040) | ABBOTT MEDICAL | 2019-05-20 |
| Advisa DR IPG, Advisa DR MRI VR ICD, Advisa DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR IPG, Astra X (P980035/S590) | Medtronic, Inc. | 2019-05-20 |
| 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/S666) | Medtronic Cardiac Rhythm Disease Management | 2019-05-20 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal COrd (P840001/S384) | Medtronic Neuromodulation | 2019-05-20 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Protecta ICD, Pro (P980016/S706) | Medtronic Cardiac Rhythm Disease Management | 2019-05-20 |
| Life Vest Wearable Defibrillator (P010030/S117) | Zoll Manufacturing Corporation | 2019-05-20 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S404) | Medtronic, Inc. | 2019-05-20 |
| Biocor, Biocor Supra, Epic, and Epic Supra Valves (P040021/S041) | ABBOTT MEDICAL | 2019-05-20 |
| Adapta, Versa, and Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, (P980035/S591) | Medtronic, Inc. | 2019-05-20 |
| Epicardial Patch Lead (P900061/S153) | Medtronic Cardiac Rhythm Disease Management | 2019-05-20 |
| InterStim Therapy System, Verify Evaluation System (Bowel Neurostimulators) (P080025/S182) | Medtronic Neuromodulation | 2019-05-17 |
| SURGICEL Absorbable Hemostats (N12159/S056) | ETHICON, Inc. | 2019-05-17 |
| Radiesse Injectable Implant (P050037/S094) | Merz North America, Inc. | 2019-05-17 |
| Radiessse Hands, and Radiesse (+) Lidocaine Dermal Filler (P050052/S111) | Merz North America, Inc. | 2019-05-17 |
| LCS Total Knee System (P830055/S230) | Depuy, Inc. | 2019-05-17 |
| RESTYLANE (P040024/S103) | Q-Med AB | 2019-05-17 |
| InterStim Therapy System, Verify Evaluation System (Urinary Neurostimulator) (P970004/S287) | Medtronic Neuromodulation | 2019-05-17 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S432) | Medtronic Neuromodulation | 2019-05-17 |
| Vistakon (etafilcon A) Brand Contact Lenses (N18033/S103) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2019-05-17 |
| LIFEPAK Automated External Defibrillators (AED) (P160026/S008) | Physio-Control, Inc. | 2019-05-17 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S107) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-05-17 |
| Neuroform Atlas® Stent System (P180031) | Stryker Neurovascular | 2019-05-16 |
| Praxis Extended RAS Panel (P160038/S012) | Illumina, Inc. | 2019-05-16 |
| Obalon Navigation Balloon Kit (P160001/S037) | Medtimo, Inc. | 2019-05-16 |
| Cologuard Stool DNA-Based Colorectal Cancer Screening Test (P130017/S030) | Exact Sciences Corporation | 2019-05-16 |
| MANTA Vascular Closure Device (P180025/S002) | Teleflex Medical, LLC | 2019-05-15 |