| Optune® Gio (P100034/S038) | Novocure, GmbH | 2024-12-18 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S028) | Cordis US Corporation | 2024-12-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S093) | ABBOTT MEDICAL | 2024-12-18 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S079) | Boston Scientific Corp | 2024-12-18 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S338) | ABBOTT MEDICAL | 2024-12-18 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr (P150003/S100) | Boston Scientific Corporation | 2024-12-18 |
| FoundationOne CDx (F1CDx) (P170019/S063) | Foundation Medicine, Inc. | 2024-12-18 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S092) | ABBOTT MEDICAL | 2024-12-18 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S064) | Boston Scientific Corp | 2024-12-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S092) | ABBOTT MEDICAL | 2024-12-17 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S205) | Boston Scientific Corp | 2024-12-17 |
| Implantable Miniature Telescope (IMT) (P050034/S021) | Samsara Vision, Inc. | 2024-12-17 |
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S023) | Siemens Healthcare Diagnostics | 2024-12-17 |
| INNOVA Self Expanding Stent System (P140028/S082) | Boston Scientific Corporation | 2024-12-17 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S555) | Medtronic, Inc. | 2024-12-17 |
| OrganOx metra System (P200035/S020) | Organox Limited | 2024-12-17 |
| HeartMate II Left Ventricular Assist System (P060040/S110) | ABBOTT MEDICAL | 2024-12-17 |
| Aveir VR Leadless System (P150035/S019) | ABBOTT MEDICAL | 2024-12-17 |
| Light Adjustable Lens, Light Delivery Device (P160055/S041) | Rxsight, Inc. | 2024-12-16 |
| InterStim Therapy System, Verify Evaluation System (P080025/S312) | Medtronic Neuromodulation | 2024-12-16 |
| LifeVest Wearable Defibrillator (P010030/S189) | Zoll Manufacturing Corporation | 2024-12-16 |
| GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) (P040043/S140) | W. L. Gore & Associates, Inc. | 2024-12-16 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S065) | Allergan | 2024-12-16 |
| NATRELLE Saline-Filled Breast Implants (P990074/S054) | Allergan | 2024-12-16 |
| InterStim Therapy System, Verify Evaluation System (P970004/S417) | Medtronic Neuromodulation | 2024-12-16 |
| TENEO 317 Model 2 (P990027/S024) | Technolas Perfect Vision GmbH | 2024-12-16 |
| Saluda Medical Evoke SCS System (P190002/S031) | Saluda Medical Pty, Ltd. | 2024-12-16 |
| Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric UV Absorbing Intraocular Lens (P190018/S038) | Alcon Laboratories, LLC | 2024-12-16 |
| LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S030) | DiaSorin, Inc. | 2024-12-13 |
| Avant HF, Entrant HF, Gallant HF, Neutrino NxT HF (P030054/S429) | ABBOTT MEDICAL | 2024-12-13 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S492) | Medtronic, Inc. | 2024-12-13 |
| Amplatzer Muscular VSD Occluder (P040040/S049) | ABBOTT MEDICAL | 2024-12-13 |
| Spinal Cord Stimulation (SCS) Leads, Extensions, & Adapters (P010032/S230) | ABBOTT MEDICAL | 2024-12-13 |
| Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock (P210037/S009) | Biotronik Nro, Inc. | 2024-12-13 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S008) | ABBOTT MEDICAL | 2024-12-13 |
| Deep Brain Stimulation (DBS) Extensions & Adapters (P140009/S112) | ABBOTT MEDICAL | 2024-12-13 |
| FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) (P110016/S087) | ABBOTT MEDICAL | 2024-12-13 |
| SURGICEL Powder Absorbable Hemostats (N12159/S116) | ETHICON, Inc. | 2024-12-13 |
| UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S003) | Alcon Research, LLC | 2024-12-13 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S070) | ABBOTT MEDICAL | 2024-12-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S306) | Medtronic Neuromodulation | 2024-12-13 |
| Axium Neurostimulator System (P150004/S081) | ABBOTT MEDICAL | 2024-12-13 |
| UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S003) | Alcon Research, LLC | 2024-12-13 |
| Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder (P120021/S026) | ABBOTT MEDICAL | 2024-12-13 |
| Amplatzer Septal Occluder, Amplatzer Multifenestrated Septal Occluder Cribriform (P000039/S080) | ABBOTT MEDICAL | 2024-12-13 |
| VenaSeal Closure System (P140018/S045) | Medtronic Vascular, Inc. | 2024-12-13 |
| InterStim Therapy System (P970004/S411) | Medtronic Neuromodulation | 2024-12-13 |
| Sequentia LT and Vanta Spinal Cord Stimulation Systems (P840001/S580) | Medtronic Neuromodulation | 2024-12-13 |
| GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder (P050006/S114) | W. L. Gore & Associates, Inc. | 2024-12-13 |
| DBS Neurostimulator Implantable/Activia Family (P960009/S493) | Medtronic, Inc. | 2024-12-12 |
| Drug Delivery Infusion Pump/SynchroMed (P860004/S435) | Medtronic, Inc. | 2024-12-12 |
| SNS Bowel Neurostimulator/Implantable InterStim (P080025/S308) | Medtronic Neuromodulation | 2024-12-12 |
| SCS Neurostimulators Implantable Itrel Family/Restore Family (P840001/S581) | Medtronic Neuromodulation | 2024-12-12 |
| Juvederm (P110033/S088) | Allergan | 2024-12-12 |
| Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S044) | Cardiovascular Systems, Inc. | 2024-12-12 |
| SNS Urinary Neurostimulator/Implantable InterStim (P970004/S413) | Medtronic Neuromodulation | 2024-12-12 |
| HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS (P160029/S026) | Philips Medical Systems, Inc. | 2024-12-12 |
| ReActiv8 Implantable Neurostimulation System (P190021/S008) | Mainstay Medical Limited | 2024-12-12 |
| Prometra Programmable Infusion Pump System (P080012/S074) | Infusyn Therapeutics, LLC | 2024-12-12 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| Cerene Cryotherapy Device (P180032/S020) | Channel Medsystems, Inc. | 2024-12-12 |
| Juvederm (P050047/S097) | Allergan | 2024-12-12 |
| FoundationOne Liquid CDx (F1CDx) (P190032/S024) | Foundation Medicine, Inc. | 2024-12-12 |
| Symplicity Spyral Renal Denervation System (P220026/S010) | Medtronic, Inc. | 2024-12-11 |
| RADIESSE Injectable Implant (P050037/S141) | Merz North America, Inc. | 2024-12-11 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S002) | Bausch & Lomb, Inc. | 2024-12-11 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S007) | ABBOTT MEDICAL | 2024-12-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S034) | Boston Scientific Corporation | 2024-12-11 |
| Pulsar-18 T3 Stent System (P160025/S018) | Biotronik AG | 2024-12-11 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S041) | Biotronik AG | 2024-12-11 |
| TherOx DownStream System (P170027/S016) | Zoll Circulation, Inc. | 2024-12-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S031) | Boston Scientific Corporation | 2024-12-11 |
| NEUROPACE RNS SYSTEM (P100026/S096) | NeuroPace, Inc. | 2024-12-11 |
| RADIESSE Injectable Implant, RADIESSE Hands, RADIESSE (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S165) | Merz North America, Inc. | 2024-12-11 |
| RHA® Redensity, RHA®2, RHA®3, RHA®4 (P170002/S047) | Teoxane S.A. | 2024-12-10 |
| Inspire® Upper Airway Stimulation (UAS) (P130008/S115) | Inspire Medical Systems | 2024-12-10 |
| Optune Gio (P100034/S037) | Novocure, GmbH | 2024-12-10 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S876) | Medtronic Cardiac Rhythm Disease Management | 2024-12-10 |
| Wolverine Coronary Cutting Balloon (Monorail) (P950020/S144) | Boston Scientific Corp | 2024-12-10 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S009) | ABBOTT MEDICAL | 2024-12-10 |
| Belotero Balance (+) Lidocaine Dermal Filler (P090016/S062) | Merz North America, Inc. | 2024-12-10 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S910) | Medtronic Cardiac Rhythm Disease Management | 2024-12-10 |
| CapSureFix Novus Lead (P930039/S266) | Medtronic, Inc. | 2024-12-09 |
| Neuroform Atlas Stent System (P180031/S010) | Stryker Neurovascular | 2024-12-09 |
| Cordella Pulmonary Artery Sensor System (P230040/S008) | Endotronix, Inc. | 2024-12-09 |
| Mynx Control Vascular Control Device, Mynx Control Venous Vascular Control Device (P040044/S108) | Cordis US Corporation | 2024-12-09 |
| Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP (P950037/S266) | Biotronik, Inc. | 2024-12-06 |
| therascreen FGFR RGQ PCR Kit (P180043/S008) | QIAGEN GmbH | 2024-12-06 |
| Venovo Venous Stent System (P180037/S014) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| Enitra 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Enitra 8 HF-T QP, Evity 8 HF-T, Evity 8 HF-T QP (P070008/S162) | Biotronik, Inc. | 2024-12-06 |
| CardioMEMS HF System (P100045/S080) | ABBOTT MEDICAL | 2024-12-06 |
| Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027) | Hologic, Inc. | 2024-12-06 |
| Gambro Prismaflex TPE 2000 Set (P830063/S029) | Vantive US Healthcare, LLC | 2024-12-06 |
| Acticor 7 DR-T DF4 ProMRI, Rivacor 3 DR-T DF4 ProMRI, Rivacor 5 DR-T DF4 ProMRI, Rivacor 7 DR-T DF4 ProMRI, Acticor 7 HF (P050023/S189) | Biotronik, Inc. | 2024-12-06 |
| Intica Neo 5 DR-T DF-1 ProMRI, Ilivia Neo 7 DR-T DF-1 ProMRI, Intica Neo 7 DR-T DF-1 ProMRI (P000009/S116) | Biotronik, Inc. | 2024-12-06 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S013) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| Ilivia Neo 7 VR-T DF-1 ProMRI, Ilivia Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 5 VR-T DF-1 ProMRI, Intica Neo 5 VR-T DX DF- (P980023/S132) | Biotronik, Inc. | 2024-12-06 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S415) | Medtronic Neuromodulation | 2024-12-05 |
| Minerva ES Endometrial Ablation System (P140013/S017) | Axora Medical, Inc. | 2024-12-05 |
| SURGICEL Absorbable Hemostats (SURGICEL Endoscopic Applicator) (N12159/S117) | ETHICON, Inc. | 2024-12-05 |