| Alinity i Total PSA Assay (P910007/S051) | Abbott Laboratories | 2020-08-07 |
| Cardinal Health Multifunctional Defibrillation Electrode (P190007) | Cardinalhealth | 2020-08-07 |
| Myocardial Pacing Lead (P120017/S023) | Medtronic, Inc. | 2020-08-06 |
| PRO-Kinetic Energy Stent System (P160003/S010) | Biotronik AG | 2020-08-06 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S444) | Medtronic, Inc. | 2020-08-06 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S122) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S433) | Medtronic, Inc. | 2020-08-06 |
| CapSure Epicardial Pacing Lead (P950024/S094) | Medtronic, Inc. | 2020-08-06 |
| LIAISON XL MUREX Anti-HBc (P180038/S002) | DiaSorin, Inc. | 2020-08-06 |
| EMBLEM S-ICD Pulse Generator (P110042/S140) | Boston Scientific Corporation | 2020-08-06 |
| LIAISON XL MUREX Anti-HBs (P180039/S001) | DiaSorin, Inc. | 2020-08-06 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S149) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| GORE CARDIOFORM ASD Occluder (P050006/S084) | W. L. Gore & Associates, Inc. | 2020-08-06 |
| Epicardial Patch Lead (P900061/S160) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead (P080006/S150) | Medtronic, Inc. | 2020-08-06 |
| Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT (P910023/S431) | ABBOTT MEDICAL | 2020-08-06 |
| CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead (P830061/S184) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| HeartWare HVAD System (P100047/S151) | Medtronic | 2020-08-06 |
| LIAISON QuantiFERON - TB Gold Plus (P180047/S004) | DiaSorin, Inc. | 2020-08-06 |
| Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT (P030054/S383) | ABBOTT MEDICAL | 2020-08-06 |
| CapSureFix MRI Lead (P090013/S308) | Medtronic, Inc. | 2020-08-06 |
| LIAISON XL MUREX HCV Ab (P190011/S002) | DiaSorin, Inc. | 2020-08-06 |
| CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S214) | Medtronic, Inc. | 2020-08-06 |
| Y Adaptor/Extender Kit, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Su (P920015/S245) | Medtronic, Inc. | 2020-08-06 |
| Transvene CS/SVC Lead (P980050/S128) | Medtronic, Inc. | 2020-08-06 |
| Attain StarFix Lead (P060039/S101) | Medtronic, Inc. | 2020-08-06 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S633) | Medtronic, Inc. | 2020-08-05 |
| Superion Indirect Decompression (IDS) System (P140004/S018) | Boston Scientific Neuromodulation | 2020-08-05 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S117) | W. L. Gore & Associates, Inc. | 2020-08-05 |
| AFX Endovascular AAA System (P040002/S066) | Endologix, LLC | 2020-08-05 |
| coflex® Interlaminar Technology (P110008/S012) | Companion Spine France | 2020-08-05 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S634) | Medtronic, Inc. | 2020-08-04 |
| Impella RP System (P170011/S025) | Abiomed, Inc. | 2020-08-04 |
| CardioMEMS HF System (P100045/S043) | ABBOTT MEDICAL | 2020-08-04 |
| LifeVest Wearable Defibrillator (P010030/S138) | Zoll Manufacturing Corporation | 2020-08-04 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist (P140003/S072) | Abiomed, Inc. | 2020-08-04 |
| Micra AV TPS, Micra TPS (P150033/S079) | Medtronic, Inc. | 2020-08-04 |
| EverFlex Self-expanding Peripheral Stent System (SFA/PPA) and EverFlex Self-expanding Peripheral Stent System (iliac) (P110023/S029) | Medtronic Vascular, Inc. | 2020-08-04 |
| NeuroPace RNS System (P100026/S082) | NeuroPace, Inc. | 2020-08-04 |
| Protege GPS Self-expanding Peripheral Stent System (P060001/S029) | Medtronic Vascular, Inc. | 2020-08-04 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S749) | Medtronic Cardiac Rhythm Disease Management | 2020-08-04 |
| 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, Cobalt (P010031/S709) | Medtronic Cardiac Rhythm Disease Management | 2020-08-04 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S443) | Medtronic, Inc. | 2020-08-04 |
| One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery (P980040/S119) | Johnson & Johnson Surgical Vision, Inc. | 2020-08-03 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S750) | Medtronic Cardiac Rhythm Disease Management | 2020-08-03 |
| ORIGEN, INOGEN, DYNAGEN MINI ICD VR/DR, ORIGEN, MOMENTUM, INOGEN, DYNAGEN, VIGILANT, RESONATE EL ICD VR/DR, ICD AUTOGEN, (P960040/S452) | Boston Scientific | 2020-08-03 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S066) | Zimmer, Inc. | 2020-08-03 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S635) | Medtronic, Inc. | 2020-08-03 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S141) | Boston Scientific Corporation | 2020-08-03 |
| HeartStart Home Defibrillator and HeartStart Onsite Defibrillator (P160029/S005) | Philips Medical Systems, Inc. | 2020-08-03 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S198) | Guidant Corp. | 2020-08-03 |
| Micra AV TPS, Micra TPS (P150033/S080) | Medtronic, Inc. | 2020-08-03 |
| HeartStart FR3 Defibrillator (P160028/S001) | Philips Medical Systems, Inc. | 2020-08-03 |
| BD Onclarity HPV Assay (P160037/S007) | Becton, Dickinson and Company | 2020-08-03 |
| Micra AV TPS, Micra TPS (P150033/S082) | Medtronic, Inc. | 2020-08-03 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S445) | Medtronic, Inc. | 2020-08-03 |
| HeartStart FRx Defibrillator (P180028/S002) | Philips Medical Systems | 2020-08-03 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S097) | Boston Scientific | 2020-08-03 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S521) | Boston Scientific Corp | 2020-08-03 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S252) | Boston Scientific Corp | 2020-08-03 |
| 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, Cobalt (P010031/S710) | Medtronic Cardiac Rhythm Disease Management | 2020-08-03 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S175) | W. L. Gore & Associates, Inc. | 2020-07-31 |
| TREO Abdominal Stent-Graft System (P190015/S001) | Bolton Medical, Inc. | 2020-07-31 |
| GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S116) | W. L. Gore & Associates, Inc. | 2020-07-31 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S020) | Bimini Health Tech | 2020-07-31 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S036) | Cook Ireland, Ltd. | 2020-07-31 |
| Therakos CELLEX Photopheresis System (P860003/S102) | Therakos Development Limited | 2020-07-31 |
| ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Reagent Kit, ARCHITECT HBsAg Qualitative Confirmato (P110029/S033) | Abbott Laboratories | 2020-07-30 |
| Epic Vascular Self-Expanding Stent System (P110035/S060) | Boston Scientific Corp | 2020-07-30 |
| NATRELLE Silicon-Filled Breast Implants (P020056/S051) | Allergan | 2020-07-30 |
| Micra AV TPS (P150033/S078) | Medtronic, Inc. | 2020-07-30 |
| NATRELLE Style 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S032) | Allergan | 2020-07-30 |
| Neuroform Atlas® Stent System (P180031/S001) | Stryker Neurovascular | 2020-07-30 |
| AMS 800 Artificial Urinary Sphincter (P000053/S114) | Boston Scientific Corp | 2020-07-30 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) (P080025/S197) | Medtronic Neuromodulation | 2020-07-30 |
| AMS 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis (N970012/S179) | Boston Scientific Corp | 2020-07-30 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S049) | Abbott Diabetes Care, Inc. | 2020-07-30 |
| NATRELLE Saline-Filled Breast Implants (P990074/S044) | Allergan | 2020-07-30 |
| Hydro Thermablator Endometrial Ablation System (P000040/S039) | Axora Medical, Inc. | 2020-07-30 |
| RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S124) | Merz North America, Inc. | 2020-07-30 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S302) | Medtronic Neuromodulation | 2020-07-30 |
| FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S043) | Abbott Diabetes Care, Inc. | 2020-07-30 |
| RADIESSE Injectable Implant (P050037/S106) | Merz North America, Inc. | 2020-07-30 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S034) | Boston Scientific Corp | 2020-07-30 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S061) | Boston Scientific Corporation | 2020-07-30 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar (P010015/S442) | Medtronic, Inc. | 2020-07-29 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S632) | Medtronic, Inc. | 2020-07-29 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S017) | Physio-Control, Inc. | 2020-07-29 |
| KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System (P050027/S025) | KARL STORZ Endoscopy-America, Inc. | 2020-07-29 |
| Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S088) | CooperVision, Inc. | 2020-07-28 |
| Biofinity (comfilcon A) soft (hydrophilic) contact lenses for extended wear (P080011/S108) | CooperVision, Inc. | 2020-07-28 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S019) | Boston Scientific Corporation | 2020-07-28 |
| Nucleus Hybrid L24 Implant System (P130016/S042) | Cochlear Americas | 2020-07-28 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S107) | CooperVision, Inc. | 2020-07-28 |
| HER2 Dual ISH DNA Probe Cocktail (P190031) | Ventana Medical Systems, Inc. | 2020-07-28 |
| CardioMEMS HF System (P100045/S044) | ABBOTT MEDICAL | 2020-07-28 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S019) | Boston Scientific Corporation | 2020-07-28 |
| LIFEPAKAutomated External Defibrillators (AEDs) (P160026/S016) | Physio-Control, Inc. | 2020-07-28 |
| FoundationOne CDx (F1CDx) (P170019/S019) | Foundation Medicine, Inc. | 2020-07-24 |
| MyCareLink Network, Micra AV family of pacemakers (P890003/S430) | Medtronic, Inc. | 2020-07-24 |