| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Microny II SR+ (P970013/S098) | ABBOTT MEDICAL | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| LCS® Total Knee System - MBT Thick Tray (P830055/S344) | Depuy, Inc. | 2025-05-21 |
| HeartMate 3 Left Ventricular Assist System (P160054/S106) | ABBOTT MEDICAL | 2025-05-21 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S317) | Medtronic Neuromodulation | 2025-05-21 |
| MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S079) | Mentor Corp. | 2025-05-21 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S119) | ABBOTT MEDICAL | 2025-05-21 |
| InterStim® Therapy System,Verify® Evaluation System (P970004/S422) | Medtronic Neuromodulation | 2025-05-21 |
| MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES (P990075/S062) | Mentor Worldwide, LLC | 2025-05-21 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S054) | Mentor Worldwide, LLC | 2025-05-21 |
| Master Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify®, (P840001/S593) | Medtronic Neuromodulation | 2025-05-21 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense TM (P960009/S505) | Medtronic, Inc. | 2025-05-21 |
| SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters (P860004/S442) | Medtronic, Inc. | 2025-05-21 |
| Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device) (P160021/S047) | W. L. Gore & Associates, Inc. | 2025-05-20 |
| Bulkamid Urethral Bulking System (P170023/S022) | Boston Scientific Corporation | 2025-05-20 |
| ROTAPRO Rotational Atherectomy System (P900056/S219) | Boston Scientific Corp | 2025-05-20 |
| ProACT Adjustable Continence Therapy for Men (P130018/S003) | Uromedica, Inc. | 2025-05-20 |
| Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems (P150031/S083) | Boston Scientific Corp | 2025-05-20 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) (P230023/S006) | W. L. Gore & Associates, Inc. | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| GenVisc 850 (P140005/S006) | Channel-Markers Medical, LLC | 2025-05-20 |
| Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses Extended Wear (P080011/S188) | CooperVision, Inc. | 2025-05-20 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S188) | Edwards Lifesciences, LLC | 2025-05-20 |
| TriVisc (P160057/S003) | Channel-Markers Medical, LLC | 2025-05-20 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S065) | Edwards Lifesciences, LLC | 2025-05-20 |
| VenaSeal Closure System (P140018/S044) | Medtronic Vascular, Inc. | 2025-05-20 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S044) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-05-20 |
| Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra (P110019/S135) | Abbott Vascular | 2025-05-19 |
| Zenith Dissection Endovascular System (P180001/S015) | William Cook Europe Aps | 2025-05-19 |
| Light Adjustable Lens and Light Delivery Device (P160055/S044) | Rxsight, Inc. | 2025-05-19 |
| MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (P100009/S074) | ABBOTT MEDICAL | 2025-05-18 |
| TriClip G4 Delivery System;TriClip G5 Delivery System (P230007/S012) | ABBOTT MEDICAL | 2025-05-18 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S122) | Inspire Medical Systems | 2025-05-16 |
| SCS System (P010032/S235) | ABBOTT MEDICAL | 2025-05-16 |
| DBS System (P140009/S117) | ABBOTT MEDICAL | 2025-05-16 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S012) | Ventana Medical Systems, Inc. | 2025-05-16 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S054) | Biotronik AG | 2025-05-15 |
| Epsila EV Transverse Tunneling Tool (P220012/S044) | Medtronic, Inc. | 2025-05-15 |
| INCRAFT® AAA Stent Graft System (P150002/S012) | Cordis US Corporation | 2025-05-15 |
| CardioMEMS HF System (P100045/S081) | ABBOTT MEDICAL | 2025-05-15 |
| S.M.A.R.T.® CONTROL® Nitinol Stent System, S.M.A.R.T. RADIANZTM Vascular Stent System (P020036/S056) | Cordis US Corporation | 2025-05-15 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| EXOSEAL® Vascular Closure Device (P100013/S030) | Cordis US Corporation | 2025-05-15 |
| CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V (P900060/S068) | Corcym S.r.l. | 2025-05-15 |
| EndoForce Connector for Endovascular Venous Anastomosis (P240004) | Phraxis, Inc. | 2025-05-15 |
| S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems, S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S031) | Cordis US Corporation | 2025-05-15 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S191) | Medtronic, Inc. | 2025-05-14 |
| VENTANA MET (SP44) RxDx Assay (P240037) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2025-05-14 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S027) | CooperVision, Inc. | 2025-05-14 |
| ColoSense (P230001/S005) | Geneoscopy, Inc. | 2025-05-14 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S013) | Endotronix, Inc. | 2025-05-13 |
| InterStimTM Therapy System, Verify® Evaluation System (P080025/S318) | Medtronic Neuromodulation | 2025-05-13 |
| InterStimTM Therapy System, Verify® Evaluation System (P970004/S423) | Medtronic Neuromodulation | 2025-05-13 |
| LifeVest® Wearable Defibrillator (P010030/S192) | Zoll Manufacturing Corporation | 2025-05-13 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S041) | Medtronic, Inc. | 2025-05-13 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S014) | Endotronix, Inc. | 2025-05-13 |
| Light Adjustable Lens and Light Delivery Device (P160055/S048) | Rxsight, Inc. | 2025-05-12 |
| NEUROPACE RNS SYSTEM (P100026/S098) | NeuroPace, Inc. | 2025-05-12 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S121) | Inspire Medical Systems | 2025-05-09 |
| HeartStart FR3 Defibrillator (P160028/S006) | Philips Medical Systems, Inc. | 2025-05-09 |
| Mynx Control Vascular Closure Device (P040044/S109) | Cordis US Corporation | 2025-05-09 |
| TRIDYNE Vascular Sealant (P150016/S025) | Neomend, Inc. | 2025-05-09 |
| MITRACLIP DELIVERY SYSTEM (P100009/S071) | ABBOTT MEDICAL | 2025-05-09 |
| Neuroform Atlas Stent System (P180031/S011) | Stryker Neurovascular | 2025-05-09 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S089) | Intera Oncology | 2025-05-09 |
| PROGEL Pleural Air Leak Sealant (P010047/S070) | Neomend, Inc. | 2025-05-09 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS (P060001/S047) | Medtronic Vascular, Inc. | 2025-05-09 |
| EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S058) | Medtronic Vascular, Inc. | 2025-05-09 |
| VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; nGEN (TM) Pump (P240006/S001) | Biosense Webster, Inc. | 2025-05-09 |
| TriClip G4 System (P230007/S010) | ABBOTT MEDICAL | 2025-05-09 |
| MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump (P160017/S123) | Medtronic Minimed, Inc. | 2025-05-09 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S105) | ABBOTT MEDICAL | 2025-05-08 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |
| HeartMate II Left Ventricular Assist System (P060040/S118) | ABBOTT MEDICAL | 2025-05-08 |
| JUVEDERM VOLUMA XC (P110033/S098) | Allergan | 2025-05-08 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S125) | Medtronic Vascular | 2025-05-08 |
| XPS with Steen Solution Perfusate (P180014/S012) | Xvivo Perfusion, Inc. | 2025-05-08 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S041) | ZOLL Medical Corporation | 2025-05-07 |
| Navitor Transcatheter Aortic Valve Implantation System (P190023/S025) | ABBOTT MEDICAL | 2025-05-07 |
| remede System (P160039/S011) | Respicardia | 2025-05-07 |
| Protégé RX Carotid Stent System; Protégé GPS Self-expanding Peripheral Stent System (P060001/S048) | Medtronic Vascular, Inc. | 2025-05-07 |
| Intera 3000 Hepatic Arterial Infusion Pump (P890055/S090) | Intera Oncology | 2025-05-07 |
| Altius Direct Electrical Nerve Stimulation System (P230020/S002) | Neuros Medical, Inc. | 2025-05-06 |
| CapSureFix MRI Lead (P090013/S333) | Medtronic, Inc. | 2025-05-06 |
| LungFit PH (P200044/S011) | Beyond Air, Inc. | 2025-05-06 |
| LungFit PH (P200044/S010) | Beyond Air, Inc. | 2025-05-06 |
| CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead (P930039/S263) | Medtronic, Inc. | 2025-05-06 |
| MitraClip G4 Clip Delivery System (P100009/S072) | ABBOTT MEDICAL | 2025-05-06 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S090) | ABBOTT MEDICAL | 2025-05-06 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S095) | St Jude Medical | 2025-05-06 |
| EXCOR Connecting and Extension Sets (P160035/S050) | Berlin Heart, Inc. | 2025-05-06 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D (P130013/S075) | Boston Scientific Corp | 2025-05-05 |
| HeartWare HVAD System (P100047/S226) | Medtronic | 2025-05-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S026) | CooperVision, Inc. | 2025-05-05 |
| VNS THERAPY SYSTEM (P970003/S247) | LivaNova USA, Inc. | 2025-05-02 |
| LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055/S047) | Rxsight, Inc. | 2025-05-02 |
| INTACS® Corneal Implants (P980031/S014) | Addition Technology | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |