| NeuroPace® RNS® System (P100026/S099) | NeuroPace, Inc. | 2025-08-18 |
| MitraClip Delivery System (P100009/S079) | ABBOTT MEDICAL | 2025-08-18 |
| SUPARTZ FX (P980044/S064) | Seikagaku Corp. | 2025-08-18 |
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| TriClip Delivery System (P230007/S016) | ABBOTT MEDICAL | 2025-08-18 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Sten (P110019/S136) | Abbott Vascular | 2025-08-16 |
| AVEIR AR 2 LSP203A Leadless Pacemaker (LP) (atrial) (P150035/S029) | ABBOTT MEDICAL | 2025-08-15 |
| HexaGen RF Generator, HexaPulse PF Generator, HexaFlow Irrigation Pump (P240013/S013) | Medtronic, Inc. | 2025-08-15 |
| Idylla CDx MSI Test (P250005) | Biocartis Us, Inc. | 2025-08-15 |
| MMR IHC Panel pharmDx (Dako Omnis) (P250004) | Agilent Technologies, Inc. | 2025-08-15 |
| Senza® HFX iQ System (P130022/S067) | Nevro Corporation | 2025-08-15 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S060) | Medinol, Ltd. | 2025-08-15 |
| Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2) (P150033/S212) | Medtronic, Inc. | 2025-08-15 |
| Neuspera Sacral Neuromodulation System (P240031/S001) | Neuspera Medical, Inc. | 2025-08-15 |
| Pipeline Vantage Embolization Device with Shield Technology (P100018/S048) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-08-14 |
| ColoSense® (P230001/S010) | Geneoscopy, Inc. | 2025-08-14 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve; Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtroni (P130021/S177) | Medtronic, Inc. | 2025-08-14 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm (hereafter ref (P110033/S101) | Allergan | 2025-08-14 |
| Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra XC and Ultra Plus XC) (P050047/S105) | Allergan | 2025-08-14 |
| ROTABLATOR Rotational Atherectomy System (P900056/S221) | Boston Scientific Corp | 2025-08-14 |
| Titan Inflatable Penile Prosthesis (P000006/S071) | Coloplast Corp. | 2025-08-14 |
| Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (P840001/S602) | Medtronic Neuromodulation | 2025-08-14 |
| FARAPULSE Pulsed Field Ablation System (P230030/S014) | Farapulse, Inc. | 2025-08-14 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S146) | Boston Scientific | 2025-08-14 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| POLARx Cryoablation System (P220032/S011) | Boston Scientific Corporation | 2025-08-14 |
| IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) (P060005/S022) | Siemens Medical Solutions Diagnostics Limited | 2025-08-14 |
| OPRA Implant System (P190009/S009) | Integrum AB | 2025-08-14 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S089) | Boston Scientific Corp | 2025-08-14 |
| Blazer II Cardiac Ablation System and Cable (P920047/S137) | Boston Scientific Corp | 2025-08-14 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S017) | Endotronix, Inc. | 2025-08-14 |
| Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System (P230013/S016) | Edwards Lifesciences, LLC | 2025-08-13 |
| LifeVest® Wearable Defibrillator, Model 4000 (P010030/S196) | Zoll Manufacturing Corporation | 2025-08-13 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S013) | Bard Peripheral Vascular, Inc. | 2025-08-13 |
| Avive Automated External Defibrillator (AED) System (P210015/S007) | Avive Solutions, Inc. | 2025-08-13 |
| Protege RX Carotid Stent System (P060001/S051) | Medtronic Vascular, Inc. | 2025-08-13 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1;Brav (P010031/S900) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| Saline and SPECTRUM Saline-Filled Breast Implants (P990075/S063) | Mentor Worldwide, LLC | 2025-08-12 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Srome MRI ICD (P980016/S932) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S898) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CR T- (P010015/S568) | Medtronic, Inc. | 2025-08-12 |
| ClearView 3 Lens (P200020/S009) | Lenstec, Inc. | 2025-08-12 |
| Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM (P090022/S046) | Lenstec, Inc. | 2025-08-12 |
| Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (P980016/S934) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S099) | Medtronic, Inc. | 2025-08-12 |
| MemoryShape Silicone Gel-Filled Breast Implants (P060028/S055) | Mentor Worldwide, LLC | 2025-08-12 |
| Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S214) | Medtronic, Inc. | 2025-08-12 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S080) | Mentor Corp. | 2025-08-12 |
| Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED (P980035/S820) | Medtronic, Inc. | 2025-08-12 |
| Aurora EV ICD DVEA3E4 (P220012/S056) | Medtronic, Inc. | 2025-08-12 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S044) | Medtronic Vascular, Inc. | 2025-08-12 |
| Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Se (P010015/S569) | Medtronic, Inc. | 2025-08-12 |
| FARAPULSE Pulsed Field Ablation System (P230030/S015) | Farapulse, Inc. | 2025-08-12 |
| 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/S818) | Medtronic, Inc. | 2025-08-12 |
| Optune Lua (P230042/S001) | Novocure, GmbH | 2025-08-12 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S097) | Medtronic, Inc. | 2025-08-12 |
| CareLink SmartSync Device Manager Base (P890003/S482) | Medtronic, Inc. | 2025-08-12 |
| MENTOR Saline-Filled and SPECTRUM Breast Implants (P990075/S064) | Mentor Worldwide, LLC | 2025-08-08 |
| Vysis CLL Fish Probe Kit (P150041/S007) | Abbott Molecular, Inc. | 2025-08-08 |
| Oncomine Dx Target Test (P160045/S049) | Life Technologies Corporation | 2025-08-08 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S013) | ABBOTT MEDICAL | 2025-08-08 |
| MENTOR MemoryShape Breast Implants (P060028/S056) | Mentor Worldwide, LLC | 2025-08-08 |
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S082) | Mentor Corp. | 2025-08-08 |
| Impella CP with SmartAssist System (P140003/S124) | Abiomed, Inc. | 2025-08-08 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S066) | Boston Scientific Corp | 2025-08-08 |
| Genio® System 2.1 (P240024) | Nyxoah S.A. | 2025-08-08 |
| lnnova Vascular Self Expanding Stent (P140028/S083) | Boston Scientific Corporation | 2025-08-08 |
| Epic Vascular Self-Expanding Stent System (P110035/S074) | Boston Scientific Corp | 2025-08-08 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S021) | ABBOTT MEDICAL | 2025-08-07 |
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oncomine Dx Express Test (P240040/S001) | Life Technologies Corporation | 2025-08-07 |
| VARIPULSE Platform; VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump (P240006/S010) | Biosense Webster, Inc. | 2025-08-07 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S059) | Medinol, Ltd. | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S201) | W. L. Gore & Associates, Inc. | 2025-08-07 |
| Angio-Seal Vascular Closure Device (P930038/S106) | Terumo Medical Corporation | 2025-08-07 |
| cobas® HPV (P190028/S020) | Roche Molecular Systems, Inc. | 2025-08-07 |
| cobas® HBV (P150014/S057) | Roche Molecular Systems, Inc. | 2025-08-07 |
| Nucleus® 24 Cochlear Implant System (P970051/S235) | Cochlear Americas | 2025-08-06 |
| Consulta CRT-P (C4TR01); Syncra CRT-P (C2TR01) (P010015/S567) | Medtronic, Inc. | 2025-08-06 |
| InterStim Therapy System, Verify Evaluation System (P970004/S432) | Medtronic Neuromodulation | 2025-08-06 |
| Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01) (P980035/S817) | Medtronic, Inc. | 2025-08-06 |
| InterStim Therapy System, Verify Evaluation System (P080025/S327) | Medtronic Neuromodulation | 2025-08-06 |
| Master Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems (P840001/S603) | Medtronic Neuromodulation | 2025-08-06 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S515) | Medtronic, Inc. | 2025-08-06 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012) | Medtronic Minimed, Inc. | 2025-08-06 |
| Mentor MemoryGel® Breast Implants (P030053/S072) | Mentor Corp. | 2025-08-06 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020/S007) | Sirtex Medical, Inc. | 2025-08-05 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S056) | Medtronic Vascular, Inc. | 2025-08-05 |
| LCS® Total Knee System (P830055/S347) | Depuy, Inc. | 2025-08-05 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| Embrace(TM) Hydrogel Embolic System (P250003) | Instylla, Inc. | 2025-08-05 |
| MANTA Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L (P180025/S014) | Teleflex Medical, LLC | 2025-08-05 |
| MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System (P140002/S029) | Terumo Medical Corporation | 2025-08-05 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S022) | Abbott Molecular, Inc. | 2025-08-05 |
| Avant VR (CDVRA700Q, CDVRA700T); Neutrino NxT VR (CDVRA800Q, CDVRA800T CDVRA600Q, CDVRA600T); Gallant VR (CDVRA500Q, (P910023/S481) | ABBOTT MEDICAL | 2025-08-04 |
| T-SPOT.TB TEST (P070006/S027) | Oxford Immunotec, Ltd. | 2025-08-04 |
| T-SPOT.TB Test (P070006/S028) | Oxford Immunotec, Ltd. | 2025-08-04 |
| IC-8 Apthera Intraocular Lens (IOL) (P210005/S011) | Acu Focus, Inc. | 2025-08-04 |