| Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S590) | Medtronic Neuromodulation | 2025-03-14 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S502) | Medtronic, Inc. | 2025-03-14 |
| InterStim Therapy System, Verify Evaluation System (P080025/S315) | Medtronic Neuromodulation | 2025-03-14 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S441) | Medtronic, Inc. | 2025-03-14 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxe (P140010/S089) | Medtronic, Inc. | 2025-03-14 |
| BRIO NEUROSTIMULATION SYSTEM (P140009/S115) | ABBOTT MEDICAL | 2025-03-13 |
| ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET (P830055/S325) | Depuy, Inc. | 2025-03-13 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S233) | ABBOTT MEDICAL | 2025-03-13 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S042) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-03-13 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222) | Medtronic | 2025-03-13 |
| Harmony Transcatheter Pulmonary Valve (P200046/S037) | Medtronic, Inc. | 2025-03-13 |
| CoreValve Evolut PRO Transcatheter Aortic Valve; Evolut PRO+ Transcatheter Aortic Valve; Evolut FX Transcatheter Aortic (P130021/S173) | Medtronic, Inc. | 2025-03-13 |
| Spinal Cord Stimulation (SCS) External Pulse Generator (EPG) (P010032/S231) | ABBOTT MEDICAL | 2025-03-12 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim (P150004/S074) | ABBOTT MEDICAL | 2025-03-12 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S024) | Ventana Medical Systems, Inc. | 2025-03-12 |
| Dorsal Root Ganglion (DRG) External Pulse Generator (EPG) (P150004/S082) | ABBOTT MEDICAL | 2025-03-12 |
| Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S182) | CooperVision, Inc. | 2025-03-12 |
| Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve (P150011/S028) | Corcym S.r.l. | 2025-03-12 |
| Shield (P230009/S005) | Guardant Health, Inc. | 2025-03-12 |
| HeartMate 3 Left Ventricular Assist System (P160054/S098) | ABBOTT MEDICAL | 2025-03-12 |
| Deep Brain Stimulation (DBS) External Pulse Generator (EPG) (P140009/S113) | ABBOTT MEDICAL | 2025-03-12 |
| Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S053) | The Cooper Companies | 2025-03-12 |
| EXCOR® Apex Cannulae (P160035/S048) | Berlin Heart, Inc. | 2025-03-11 |
| Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD (P810031/S079) | Johnson & Johnson Surgical Vision, Inc. | 2025-03-11 |
| Minima Stent System (P240003/S003) | Renata Medical, Inc. | 2025-03-11 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S019) | W. L. Gore and Associates, Inc. | 2025-03-11 |
| Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q (P050023/S190) | Biotronik, Inc. | 2025-03-10 |
| Pamira S DX 65/15, Pamira S DX 65/17, Plexa ProMRI S DX 65/15, Plexa ProMRI S DX 65/17 (P980023/S133) | Biotronik, Inc. | 2025-03-10 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S010) | Farapulse, Inc. | 2025-03-10 |
| Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60 (P950037/S267) | Biotronik, Inc. | 2025-03-10 |
| Corox (ProMRI) OTW 75 BP, Corox (ProMRI) OTW-S 75 BP, Corox (ProMRI) OTW-L 75 BP, Corox (ProMRI) OTW 85 BP, Corox (ProMR (P070008/S163) | Biotronik, Inc. | 2025-03-10 |
| StarClose SE Vascular Surgical System (P050007/S046) | Abbott Vascular Devices | 2025-03-09 |
| Supera Peripheral Stent System (P120020/S033) | Abbott Vascular (Idef Technologies Inc) | 2025-03-09 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S003) | Boston Scientific Corporation | 2025-03-09 |
| XACT Carotid Stent System (P040038/S047) | Abbott Vascular, Inc. | 2025-03-09 |
| Perclose ProGlide Suture-Mediated Closure System, Prostar XL Percutaneous Vascular Surgical System (P960043/S125) | Abbott Vascular, Inc. | 2025-03-09 |
| Parylene Tree Loading Machine (P160043/S086) | Medtronic Vascular | 2025-03-07 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S057) | Medtronic Vascular, Inc. | 2025-03-07 |
| Protégé RX Carotid Stent System; Protégé GPS Self-Expanding Peripheral Stent System (P060001/S046) | Medtronic Vascular, Inc. | 2025-03-07 |
| SURGICEL SNoW Absorbable Hemostats; SURGICEL FIBRILLAR Absorbable Hemostats (N12159/S120) | ETHICON, Inc. | 2025-03-07 |
| IC-8 Apthera IOL Aperture Mask (P210005/S009) | Acu Focus, Inc. | 2025-03-07 |
| Paradise Ultrasound Renal Denervation System; Paradise Catheter (P220023/S007) | Recor Medical, Inc. | 2025-03-06 |
| SURGIFOAM Absorbable Gelatin Powder; SURGIFOAM Absorbable Gelatin Powder (P990004/S072) | Ferrosan Meidcal Devices A/S | 2025-03-06 |
| EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO), (P030016/S047) | STAAR Surgical Company | 2025-03-05 |
| ZOLL OneStep Pediatric CPR Electrode (P160022/S035) | ZOLL Medical Corporation | 2025-03-05 |
| Amplatzer Septal Occluder (P000039/S081) | ABBOTT MEDICAL | 2025-03-05 |
| CoreValve EnVeo PRO Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Transcatheter Aortic Valve (P130021/S171) | Medtronic, Inc. | 2025-03-05 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S010) | ABBOTT MEDICAL | 2025-03-05 |
| SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL FIBRILLAR Absorbable Hemostat, SUR (N12159/S112) | ETHICON, Inc. | 2025-03-05 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S011) | ABBOTT MEDICAL | 2025-03-05 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S135) | Biotronik, Inc. | 2025-03-05 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S172) | Medtronic, Inc. | 2025-03-05 |
| LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). (P910018/S037) | Kaneka Pharma America Corp. | 2025-03-05 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S271) | Biotronik, Inc. | 2025-03-05 |
| Pipeline Vantage Embolization Device with Shield Technology (Pipeline Vantage) (P100018/S049) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-03-05 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T (P050023/S195) | Biotronik, Inc. | 2025-03-05 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S119) | Biotronik, Inc. | 2025-03-05 |
| WaveLight EX500 Laser (P020050/S043) | Alcon Laboratories, Inc. | 2025-03-05 |
| Bulkamid Urethral Bulking System (P170023/S020) | Boston Scientific Corporation | 2025-03-05 |
| ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay (P110041/S015) | Siemens Corp. | 2025-03-04 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S061) | Edwards Lifesciences, LLC | 2025-03-04 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S088) | Edwards Lifesciences, LLC | 2025-03-04 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, SAPIEN 3 Ultra RESILIA Tra (P140031/S183) | Edwards Lifesciences, LLC | 2025-03-04 |
| Inspire II Upper Airway Stimulator (P130008/S119) | Inspire Medical Systems | 2025-03-04 |
| EPi-Sense and EPi-Sense ST Guided Coagulation System (P200002/S010) | AtriCure, Inc. | 2025-03-03 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S048) | Biotronik AG | 2025-03-03 |
| CALCIVIS Imaging System (P170029/S004) | Calcivis Limited | 2025-03-03 |
| EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) (P150048/S089) | Edwards Lifesciences, LLC | 2025-03-03 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| Astron (P140030/S017) | Biotronik AG | 2025-03-03 |
| Pulsar-18 T3 (P160025/S019) | Biotronik AG | 2025-03-03 |
| DETOUR System (P220021/S004) | Endologix, LLC | 2025-03-03 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S184) | Edwards Lifesciences, LLC | 2025-03-03 |
| GORE® EXCLUDER AAA Endoprosthesis; Iliac Branch Endoprosthesis (P020004/S198) | W. L. Gore & Associates, Inc. | 2025-03-03 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S501) | Medtronic, Inc. | 2025-02-28 |
| Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S002) | Agilent Technologies, Inc. | 2025-02-28 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S055) | Medtronic Vascular, Inc. | 2025-02-28 |
| PD-L1 IHC 22C3 pharmDx (P150013/S029) | Agilent Technologies, Inc. | 2025-02-28 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S314) | Medtronic Neuromodulation | 2025-02-28 |
| OrganOx metra System (P200035/S021) | Organox Limited | 2025-02-28 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S419) | Medtronic Neuromodulation | 2025-02-28 |
| MAGE-A4 IHC 1F9 pharmDx (P230016/S001) | Agilent Technologies, Inc. | 2025-02-28 |
| Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an (P840001/S589) | Medtronic Neuromodulation | 2025-02-28 |
| PD-L1 IHC 28-8 pharmDx (P150025/S016) | Agilent Technologies, Inc. | 2025-02-28 |
| CraniSeal Dural Sealant (P220014/S003) | Pramand, LLC | 2025-02-28 |
| Nucleus 24 Cochlear Implant System (P970051/S233) | Cochlear Americas | 2025-02-28 |
| Epsila EV Extravascular Lead (P220012/S042) | Medtronic, Inc. | 2025-02-27 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK (P860003/S111) | Therakos Development Limited | 2025-02-27 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P950005/S088) | Biosense Webster, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P030031/S138) | Biosense Webster, Inc. | 2025-02-26 |
| HeartMate 3 (HM3) Left Ventricular Assist System (P160054/S097) | ABBOTT MEDICAL | 2025-02-26 |
| RelayPro Thoracic Stent-Graft System (P200045/S015) | Bolton Medical, Inc. | 2025-02-26 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control ( (P100039/S016) | Siemens Healthcare Diagnostics, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P010068/S074) | Biosense Webster, Inc. | 2025-02-26 |
| SmartAblate System Interface Cable (P990071/S065) | Biosense Webster, Inc. | 2025-02-26 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S883) | Medtronic Cardiac Rhythm Disease Management | 2025-02-26 |
| HeartMate II (HMII) Left Ventricular Assist System (P060040/S114) | ABBOTT MEDICAL | 2025-02-26 |