| MicroTransponder® Vivistim® Paired VNS System (P210007/S004) | Mobia Medical, Inc. | 2025-01-24 |
| LIPOSORBER® LA-15 System (P910018/S039) | Kaneka Pharma America Corp. | 2025-01-24 |
| Paradise Ultrasound Renal Denervation System (Paradise System), Paradise Catheter (P220023/S006) | Recor Medical, Inc. | 2025-01-24 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S014) | Cook Medical Incorporated | 2025-01-23 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S136) | Boston Scientific Corp | 2025-01-23 |
| Mosaic Bioprosthesis (P990064/S089) | Medtronic, Inc. | 2025-01-22 |
| nGEN Pump (P990071/S064) | Biosense Webster, Inc. | 2025-01-22 |
| Guardant360 CDx (P200010/S023) | Guardant Health, Inc. | 2025-01-22 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S188) | Medtronic, Inc. | 2025-01-22 |
| Aurora EV-ICD (P220012/S039) | Medtronic, Inc. | 2025-01-22 |
| Hancock II Bioprosthesis (P980043/S080) | Medtronic, Inc. | 2025-01-22 |
| 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/S880) | Medtronic Cardiac Rhythm Disease Management | 2025-01-22 |
| 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/S914) | Medtronic Cardiac Rhythm Disease Management | 2025-01-22 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S054) | Medtronic Vascular, Inc. | 2025-01-21 |
| Axonics Sacral Neuromodulation System (P180046/S096) | Boston Scientific Corporation | 2025-01-21 |
| PERCEVAL PLUS SUTURELESS HEART VALVE (P150011/S031) | Corcym S.r.l. | 2025-01-21 |
| Axonics Sacral Neuromodulation System (P190006/S096) | Boston Scientific Corporation | 2025-01-21 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S010) | Endotronix, Inc. | 2025-01-17 |
| prodisc® L (P050010/S026) | Centinel Spine, LLC | 2025-01-17 |
| MediBeacon® Transdermal GFR Measurement System (TGFR) (P230019) | Medibeacon, Inc. | 2025-01-17 |
| MemoryGel Enhance Silicone Breast Implants (P030053/S076) | Mentor Corp. | 2025-01-17 |
| ManaFuse (P210016) | Enovis | 2025-01-17 |
| Rotawire Guidewire, ROTAWIRE Drive Guidewire (P900056/S218) | Boston Scientific Corp | 2025-01-17 |
| TOPS System (P220002/S005) | Premia Spine, Ltd. | 2025-01-17 |
| Juvederm Voluma XC (P110033/S090) | Allergan | 2025-01-17 |
| GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder (P050006/S111) | W. L. Gore & Associates, Inc. | 2025-01-17 |
| Gel-One (P080020/S053) | Seikagaku Corp. | 2025-01-17 |
| RHA 3 Mepi (P170002/S043) | Teoxane S.A. | 2025-01-17 |
| Axonics Sacral Neuromodulation System (P190006/S095) | Boston Scientific Corporation | 2025-01-16 |
| Minima Stent System (P240003/S002) | Renata Medical, Inc. | 2025-01-16 |
| FoundationOne CDx (P170019/S054) | Foundation Medicine, Inc. | 2025-01-16 |
| Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens (P980006/S036) | Bausch & Lomb, Inc. | 2025-01-16 |
| Aveir VR Leadless Pacemaker, Aveir DR Leadless Pacemaker (P150035/S021) | ABBOTT MEDICAL | 2025-01-16 |
| WaveLight EX500 Laser System (P030008/S039) | Alcon Laboratories, Inc. | 2025-01-16 |
| Axonics Sacral Neuromodulation System (P180046/S095) | Boston Scientific Corporation | 2025-01-16 |
| therascreen® KRAS RGQ PCR Kit (P110027/S018) | QIAGEN GmbH | 2025-01-16 |
| WaveLight EX500 Laser System (P020050/S044) | Alcon Laboratories, Inc. | 2025-01-16 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S036) | Spectranetics Corp. | 2025-01-15 |
| Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno (P120016/S038) | Cardiva Medical, Inc. | 2025-01-15 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S418) | Medtronic Neuromodulation | 2025-01-15 |
| OPRA Implant System (P190009/S007) | Integrum AB | 2025-01-15 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S034) | Siemens Healthcare Diagnostics, Inc. | 2025-01-15 |
| LIPOSORBER® LA-15 System (P910018/S036) | Kaneka Pharma America Corp. | 2025-01-15 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S500) | Medtronic, Inc. | 2025-01-15 |
| Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) (P110007/S016) | Johnson & Johnson Surgical Vision, Inc. | 2025-01-15 |
| Healon Duet® PRO Dual Pack (P810031/S077) | Johnson & Johnson Surgical Vision, Inc. | 2025-01-15 |
| SynchroMed® Infusion System (P860004/S438) | Medtronic, Inc. | 2025-01-15 |
| Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine (P090016/S065) | Merz North America, Inc. | 2025-01-15 |
| Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Intellis Spinal Cord Stimulation System, (P840001/S588) | Medtronic Neuromodulation | 2025-01-15 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S313) | Medtronic Neuromodulation | 2025-01-15 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S005) | Boston Scientific Corporation | 2025-01-14 |
| Rayner C-flex 570C, C-flex Aspheric 970C, G00C Aspheric lntraocular lenses, RayOne Aspheric RAOG00C, RayOne Spheric RAOl (P060011/S038) | Rayner Intraocular Lenses , Ltd. | 2025-01-14 |
| PROMUS Element PLUS, PREMIER, ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S213) | Boston Scientific Corp | 2025-01-14 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S870) | Medtronic Cardiac Rhythm Disease Management | 2025-01-14 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S065) | Boston Scientific Corp | 2025-01-14 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S036) | Boston Scientific Corporation | 2025-01-14 |
| Saluda Medical Evoke SCS System (P190002/S034) | Saluda Medical Pty, Ltd. | 2025-01-14 |
| TECNIS SIMPILICITY Delivery System, SmartLOAD Delivery Technology (P980040/S170) | Johnson & Johnson Surgical Vision, Inc. | 2025-01-14 |
| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S058) | Bausch & Lomb, Inc. | 2025-01-14 |
| Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S114) | Integra LifeSciences Corporation | 2025-01-14 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co (P150003/S106) | Boston Scientific Corporation | 2025-01-14 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S117) | Inspire Medical Systems | 2025-01-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S904) | Medtronic Cardiac Rhythm Disease Management | 2025-01-14 |
| 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/S796) | Medtronic, Inc. | 2025-01-14 |
| CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S094) | Integra Lifesciences Corp. | 2025-01-14 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S548) | Medtronic, Inc. | 2025-01-14 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S001) | Bausch & Lomb, Inc. | 2025-01-14 |
| Organ Care System (OCS) Liver (P200031/S007) | TransMedics, Inc. | 2025-01-13 |
| iStent inject Trabecular MicroBypass System (P170043/S020) | Glaukos Corporation | 2025-01-13 |
| Proclaim Dorsal Root Ganglion (DRG) IPG (P150004/S079) | ABBOTT MEDICAL | 2025-01-13 |
| Proclaim Spinal Cord Simulation Implantable Pulse Generator (IPG) (P010032/S227) | ABBOTT MEDICAL | 2025-01-13 |
| Infinity Deep Brain Stimulation (DBS) (P140009/S109) | ABBOTT MEDICAL | 2025-01-13 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S012) | Siemens Healthcare Diagnostics | 2025-01-13 |
| Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S055) | Abiomed, Inc. | 2025-01-10 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |
| CorPASS System (P230040/S009) | Endotronix, Inc. | 2025-01-10 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S005) | Medtronic, Inc. | 2025-01-09 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S198) | Medtronic, Inc. | 2025-01-08 |
| 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/S912) | Medtronic Cardiac Rhythm Disease Management | 2025-01-08 |
| CareLink SmartSync Device Manager Base, CareLink SmartSync Device Manager Patient Connector, MyCareLink Patient Monitor (P890003/S474) | Medtronic, Inc. | 2025-01-08 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S557) | Medtronic, Inc. | 2025-01-08 |
| Aurora EV ICD (P220012/S038) | Medtronic, Inc. | 2025-01-08 |
| Belotero Balance (+) Lidocaine Dermal Filler (P090016/S064) | Merz North America, Inc. | 2025-01-08 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S380) | Boston Scientific Corp | 2025-01-08 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S081) | Boston Scientific Corp | 2025-01-08 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S805) | Medtronic, Inc. | 2025-01-08 |
| 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/S878) | Medtronic Cardiac Rhythm Disease Management | 2025-01-08 |
| VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S006) | Ventana Medical Systems, Inc. | 2025-01-08 |
| Mara Water Vapor Ablation System (P160047/S039) | CooperSurgical, Inc. | 2025-01-07 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S004) | Medtronic, Inc. | 2025-01-07 |
| Bellafill Dermal Filler (P020012/S048) | Tiger Aesthetics Medical, LLC | 2025-01-07 |
| LifeVest Wearable Defibrillator (P010030/S190) | Zoll Manufacturing Corporation | 2025-01-07 |
| MI Cancer Seek (P240010/S002) | Caris Life Sciences | 2025-01-07 |
| Parvovirus B 19 IgM Enzyme Immunoassay (P970055/S024) | Diasorin | 2025-01-06 |
| LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe (P180049/S017) | DiaSorin, Inc. | 2025-01-06 |
| LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg (P180048/S017) | DiaSorin, Inc. | 2025-01-06 |
| Parvovirus B 19 IgG Enzyme Immunoassay (P970054/S022) | Diasorin | 2025-01-06 |
| InterStim Therapy System, Verify Evaluation System (P970004/S409) | Medtronic Neuromodulation | 2025-01-06 |
| LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus (P180047/S031) | DiaSorin, Inc. | 2025-01-06 |