| Medtronic Altaviva System (P240011) | Medtronic Neuromodulation | 2025-09-18 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S158) | Alcon Laboratories, Inc. | 2025-09-18 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator 97800); (SNS Urinary Neurostimulator I (P970004/S435) | Medtronic Neuromodulation | 2025-09-18 |
| HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (P160008/S027) | Heartsine Technologies, Ltd. | 2025-09-17 |
| Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201 (P150035/S030) | ABBOTT MEDICAL | 2025-09-17 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S085) | ABBOTT MEDICAL | 2025-09-17 |
| MarginProbe (P110014/S013) | Dilon Medical Technologies, Ltd. | 2025-09-17 |
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM (P960004/S110) | Boston Scientific | 2025-09-16 |
| ACC SUP FIXATION TOOL (P960006/S057) | Boston Scientific | 2025-09-16 |
| ACC SUP VEIN PICK (P830060/S091) | Boston Scientific | 2025-09-16 |
| ACC WRENCH (P930035/S035) | Boston Scientific | 2025-09-16 |
| ACC SUP SUTURE SLEEVE; ACC SUP FLUSHING TOOL; ACC WRENCH TORQUE-BI; ACC SUP LD CAP LV1 (P010012/S597) | Boston Scientific Corp | 2025-09-16 |
| ACC SUP PLUG (P910077/S196) | Boston Scientific | 2025-09-16 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S596) | Boston Scientific Corp | 2025-09-16 |
| IN.PACT AV Paclitaxel-coated PTA Balloon Catheter (P190008/S045) | Medtronic Vascular, Inc. | 2025-09-16 |
| IN.PACT Admiral Paclitaxelcoated PTA Balloon Catheter; IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter (P140010/S100) | Medtronic, Inc. | 2025-09-16 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S205) | Boston Scientific Corporation | 2025-09-16 |
| ACC STY TPR 0.013 - Accessory Stylet Straight, X-Soft; ACC STY 0.014 SOFT LONG TPR - Accessory Stylet Long Taper, Soft; (P150012/S171) | Boston Scientific | 2025-09-16 |
| ACC SUP CONNECTOR QUAD PSA TO IS4; ACC SUP SUTURE SLEEVE; ACC SUP KIT LD CAP; STRL PKG LEAD REPAIR KIT; ACC STY STR .016 (P910073/S183) | Boston Scientific | 2025-09-16 |
| PyloPlus Urea Breath Test System (P170022/S008) | Arj Medical, Inc. | 2025-09-16 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S509) | Boston Scientific | 2025-09-16 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S331) | Medtronic Neuromodulation | 2025-09-15 |
| Purge Cassette (P170011/S058) | Abiomed, Inc. | 2025-09-15 |
| ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses (P170035/S018) | Bausch and Lomb, Inc., | 2025-09-15 |
| Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (P840001/S607) | Medtronic Neuromodulation | 2025-09-15 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S519) | Medtronic, Inc. | 2025-09-15 |
| Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (P000009/S121) | Biotronik, Inc. | 2025-09-15 |
| ColoSense® (P230001/S009) | Geneoscopy, Inc. | 2025-09-15 |
| 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/S137) | Biotronik, Inc. | 2025-09-15 |
| Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462 (P050023/S201) | Biotronik, Inc. | 2025-09-15 |
| Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (P010031/S902) | Medtronic Cardiac Rhythm Disease Management | 2025-09-15 |
| Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (P140003/S126) | Abiomed, Inc. | 2025-09-15 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S436) | Medtronic Neuromodulation | 2025-09-15 |
| Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140; Enitra 8 HF-T QP 407141; Enitr (P070008/S170) | Biotronik, Inc. | 2025-09-15 |
| SMARTABLATE System Interface Cable (D-1303-02-S) (P990071/S067) | Biosense Webster, Inc. | 2025-09-15 |
| Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (P980016/S936) | Medtronic Cardiac Rhythm Disease Management | 2025-09-15 |
| Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (P950037/S276) | Biotronik, Inc. | 2025-09-15 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012/S003) | Medtronic Minimed, Inc. | 2025-09-12 |
| iCast Covered Stent System (P120003/S011) | Atrium Medical Corp. | 2025-09-12 |
| PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (P030047/S051) | Cordis US Corporation | 2025-09-12 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S030) | Terumo Medical Corporation | 2025-09-12 |
| S.M.A.R.T.® CONTROL® Vascular Stent System (P120002/S032) | Cordis US Corporation | 2025-09-12 |
| MiniMed 780G System (P160017/S128) | Medtronic Minimed, Inc. | 2025-09-12 |
| S.M.A.R.T.® CONTROL® Nitinol Stent System (P020036/S057) | Cordis US Corporation | 2025-09-12 |
| Simplera System (P160007/S055) | Medtronic Minimed | 2025-09-12 |
| VNS Therapy® System (P970003/S250) | LivaNova USA, Inc. | 2025-09-12 |
| Edwards EVOQUE tricuspid delivery system (P230013/S018) | Edwards Lifesciences, LLC | 2025-09-12 |
| EXCOR Cannula Clip (P160035/S049) | Berlin Heart, Inc. | 2025-09-12 |
| TECNIS Odyssey IOL with TECNIS SIMPLICITY Delivery System (DRN00V); TECNIS Odyssey Toric II IOLs with TECNIS SIMPLICITY (P980040/S174) | Johnson & Johnson Surgical Vision, Inc. | 2025-09-11 |
| Minima Stent System (P240003/S004) | Renata Medical, Inc. | 2025-09-11 |
| Aurora EV-ICD System (P220012/S054) | Medtronic, Inc. | 2025-09-11 |
| Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (P950037/S275) | Biotronik, Inc. | 2025-09-11 |
| ReCor Paradise Catheter (P220023/S009) | Recor Medical, Inc. | 2025-09-11 |
| Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 (P070008/S169) | Biotronik, Inc. | 2025-09-11 |
| Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (P050023/S200) | Biotronik, Inc. | 2025-09-11 |
| TECNIS Foldable Acrylic IOL with OptiEdge (P990080/S062) | Johnson & Johnson Surgical Vision, Inc. | 2025-09-10 |
| InterStim® Therapy System (P080025/S316) | Medtronic Neuromodulation | 2025-09-10 |
| VARIPULSE Catheter (P240006/S011) | Biosense Webster, Inc. | 2025-09-10 |
| CardioMEMSTM HF System (P100045/S084) | ABBOTT MEDICAL | 2025-09-10 |
| FINEVISION HP Trifocal IOLs (P240038) | Beaver Visitec International, Inc. | 2025-09-10 |
| TECNIS Multifocal 3-Piece IOL (P080010/S027) | Johnson & Johnson Surgical Vision, Inc. | 2025-09-10 |
| RelayPro Thoracic Stent-Graft System (P200045/S020) | Bolton Medical, Inc. | 2025-09-10 |
| SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (P980040/S171) | Johnson & Johnson Surgical Vision, Inc. | 2025-09-10 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S019) | Endotronix, Inc. | 2025-09-10 |
| InterStim® Therapy System (P970004/S421) | Medtronic Neuromodulation | 2025-09-10 |
| Alinity m HR HPV (P230003/S006) | Abbott Molecular, Inc. | 2025-09-10 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen (P900033/S115) | Integra Lifesciences Corp. | 2025-09-09 |
| Womed Leaf Resorbable Adhesion Barrier (P240015) | Womed Sas | 2025-09-09 |
| Implantable Cardioverter Defibrillator (ICD) (P980016/S931) | Medtronic Cardiac Rhythm Disease Management | 2025-09-09 |
| GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S203) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S009) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| Cardiac Resynchronization Therapy -Defibrillator (CRT-D) (P010031/S897) | Medtronic Cardiac Rhythm Disease Management | 2025-09-09 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S023) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S025) | Edwards Lifesciences, LLC | 2025-09-09 |
| Conformable GORE® TAG® Thoracic Endoprosthesis (P040043/S145) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| SURGICEL BRAND ABSORBABLE HEMOSTAT (N12159/S123) | ETHICON, Inc. | 2025-09-09 |
| SURGIFOAM® Absorbable Gelatin Sponge (P990004/S076) | Ferrosan Meidcal Devices A/S | 2025-09-08 |
| saypha® MagIQ (P240008) | Croma-Pharma GmbH | 2025-09-08 |
| OrganOx metra® System (P200035/S029) | Organox Limited | 2025-09-08 |
| Eterna SCS IPG (P010032/S240) | ABBOTT MEDICAL | 2025-09-07 |
| Liberta RC DBS IPG (P140009/S121) | ABBOTT MEDICAL | 2025-09-07 |
| VNS Therapy System (P970003/S248) | LivaNova USA, Inc. | 2025-09-05 |
| TOUCH® CMC 1 Prosthesis (P240020/S001) | Keri Medical SA | 2025-09-05 |
| InterStim® Therapy System; Verify® Evaluation System (P970004/S434) | Medtronic Neuromodulation | 2025-09-05 |
| TruSight Oncology Comprehensive (P230011/S004) | Illumina, Inc. | 2025-09-05 |
| Harmony TPV System (P200046/S043) | Medtronic, Inc. | 2025-09-05 |
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C (P010015/S570) | Medtronic, Inc. | 2025-09-05 |
| TOUCH® CMC 1 Prosthesis (P240020/S002) | Keri Medical SA | 2025-09-05 |
| Straumann Emdogain (P930021/S034) | The Straumann Company | 2025-09-05 |
| InterStim® Therapy System; Verify® Evaluation System (P080025/S329) | Medtronic Neuromodulation | 2025-09-05 |
| Percepta Bipolar CRT-P W1TR1; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P W (P980016/S935) | Medtronic Cardiac Rhythm Disease Management | 2025-09-05 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S449) | Medtronic, Inc. | 2025-09-05 |
| Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (P840001/S605) | Medtronic Neuromodulation | 2025-09-05 |
| Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01) (P150033/S216) | Medtronic, Inc. | 2025-09-05 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S517) | Medtronic, Inc. | 2025-09-05 |
| Aurora EV-ICD System (DVEA3E4) (P220012/S057) | Medtronic, Inc. | 2025-09-05 |