| Essentio MRI SR; Essentio MRI DR; L131 Essentio MRI EL DR; Proponent; Accolade MRI SR; Accolade MRI DR; Accolade MRI EL (P150012/S166) | Boston Scientific | 2025-04-11 |
| Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D (P010012/S589) | Boston Scientific Corp | 2025-04-11 |
| Abre Venous Self-expanding Stent System (P200026/S013) | Medtronic Vascular, Inc. | 2025-04-11 |
| SIR-SPHERES (P990065/S017) | Sirtex Medical, Inc. | 2025-04-11 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S015) | W. L. Gore & Associates, Inc. | 2025-04-11 |
| Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an (P840001/S592) | Medtronic Neuromodulation | 2025-04-11 |
| Axonics Sacral Neuromodulation System (P190006/S098) | Boston Scientific Corporation | 2025-04-11 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S051) | Biotronik AG | 2025-04-11 |
| D010 INOGEN MINI ICD VR; D011 INOGEN MINI ICD VR; D012 INOGEN MINI ICD DR; D013 INOGEN MINI ICD DR; D020 DYNAGEN MI (P960040/S504) | Boston Scientific | 2025-04-11 |
| Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy (P040042/S057) | Irvine Biomedical,Inc.(Ibi) | 2025-04-10 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047/S034) | DiaSorin, Inc. | 2025-04-10 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S019) | DiaSorin, Inc. | 2025-04-10 |
| PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis (P860057/S220) | Edwards Lifesciences, LLC | 2025-04-10 |
| LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038/S023) | DiaSorin, Inc. | 2025-04-10 |
| LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe (P180049/S020) | DiaSorin, Inc. | 2025-04-10 |
| FlexAbility Ablation Catheter; FlexAbility Ablation Catheter, Sensor Enabled (P110016/S088) | ABBOTT MEDICAL | 2025-04-10 |
| Therapy Ablation Catheter (4mm Tip Thermistor and Bi-Directional); Cables (P040014/S050) | Irvine Biomedical, Inc. | 2025-04-10 |
| LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory (P190017/S025) | DiaSorin, Inc. | 2025-04-10 |
| Safire Bi-Directional Ablation Catheter; Safire Catheter Extension Cable (P960016/S092) | St Jude Medical | 2025-04-10 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S017) | ABBOTT MEDICAL | 2025-04-10 |
| Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S012) | Medtronic, Inc. | 2025-04-10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S093) | St Jude Medical | 2025-04-10 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S342) | Depuy, Inc. | 2025-04-10 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039/S022) | DiaSorin, Inc. | 2025-04-10 |
| LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S006) | DiaSorin, Inc. | 2025-04-10 |
| LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg (P180048/S020) | DiaSorin, Inc. | 2025-04-10 |
| HYMOVIS ONE (P150010/S005) | Fidia Farmaceutici | 2025-04-09 |
| S.M.A.R.T.; S.M.A.R.T. CONTROL Vascular Stent Systems; S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S029) | Cordis US Corporation | 2025-04-09 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S098) | W. L. Gore & Associates, Inc. | 2025-04-09 |
| S.M.A.R.T. CONTROL Nitinol Stent System; S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S054) | Cordis US Corporation | 2025-04-09 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| HiResolution Bionic Ear System (P960058/S168) | Advanced Bionics | 2025-04-09 |
| Thoraflex Hybrid (P210006/S012) | Vascutek, Ltd. | 2025-04-09 |
| C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S040) | Rayner Intraocular Lenses , Ltd. | 2025-04-09 |
| INCRAFT AAA Stent Graft System (P150002/S011) | Cordis US Corporation | 2025-04-09 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S053) | Biotronik AG | 2025-04-09 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtronic Evolut FX Transcatheter Aortic Valve; Medtronic Evolut FX+ T (P130021/S176) | Medtronic, Inc. | 2025-04-08 |
| OPTIMIZER Smart System (P180036/S039) | Impulse Dynamics (Usa), Inc. | 2025-04-08 |
| QDOT MICRO System (P210027/S012) | Biosense Webster, Inc. | 2025-04-08 |
| SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses (P960022/S013) | Bausch & Lomb, Inc. | 2025-04-08 |
| Harmony Transcatheter Pulmonic Valve (TPV) System (P200046/S039) | Medtronic, Inc. | 2025-04-07 |
| CoreValve EnVeo Pro Delivery Catheter System; CoreValve EnVeo Pro Loading System; Evolut PRO+ Delivery Catheter System; (P130021/S175) | Medtronic, Inc. | 2025-04-07 |
| Symplicity Spyral Renal Denervation Catheter (P220026/S011) | Medtronic, Inc. | 2025-04-07 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S071) | Medtronic Vascular | 2025-04-07 |
| Harmony Delivery Catheter System (P200046/S038) | Medtronic, Inc. | 2025-04-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S102) | ABBOTT MEDICAL | 2025-04-07 |
| Endurant Stent Graft System; Endurant II Stent Graft System; Endurant II Stent AUI Graft System; Endurant IIs Stent Graf (P100021/S128) | Medtronic Vascular | 2025-04-07 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System RX and OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys (P160043/S087) | Medtronic Vascular | 2025-04-07 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S035) | Spectranetics Corp. | 2025-04-04 |
| Exablate Model 4000 System (P150038/S038) | Insightec | 2025-04-04 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| Exablate 4000; Exablate Transcarnial MRgFUS; Exablate Neuro; Exablate Prime; ExAblate Neuravive (P150038/S040) | Insightec | 2025-04-04 |
| LungFit PH (P200044/S008) | Beyond Air, Inc. | 2025-04-04 |
| PRECISE PRO RX Transcarotid Stent System (P030047/S049) | Cordis US Corporation | 2025-04-04 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| Renamic Neo (P050023/S192) | Biotronik, Inc. | 2025-04-03 |
| Renamic Neo (P000009/S118) | Biotronik, Inc. | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| Aurora EV-ICD (P220012/S047) | Medtronic, Inc. | 2025-04-03 |
| SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S108) | Boston Scientific Corporation | 2025-04-03 |
| Renamic Neo (P070008/S164) | Biotronik, Inc. | 2025-04-03 |
| Aveir VR Leadless System (P150035/S022) | ABBOTT MEDICAL | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; M (P980016/S921) | Medtronic Cardiac Rhythm Disease Management | 2025-04-03 |
| LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026/S057) | Physio-Control, Inc. | 2025-04-03 |
| Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (P010015/S560) | Medtronic, Inc. | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S011) | Farapulse, Inc. | 2025-04-03 |
| ARCHITECT AUSAB; Alinity i Anti-HBs (P050051/S061) | Abbott Laboratories, Inc. | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| Renamic Neo (P950037/S269) | Biotronik, Inc. | 2025-04-03 |
| 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/S809) | Medtronic, Inc. | 2025-04-03 |
| Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; (P010031/S887) | Medtronic Cardiac Rhythm Disease Management | 2025-04-03 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1 Brava CRT-D DTBC1D4 Brava Q (P010031/S886) | Medtronic Cardiac Rhythm Disease Management | 2025-04-02 |
| Axonics Sacral Neuromodulation System (P190006/S089) | Boston Scientific Corporation | 2025-04-02 |
| Aurora EV ICD DVEA3E4 (P220012/S046) | Medtronic, Inc. | 2025-04-02 |
| Axonics Sacral Neuromodulation System (P180046/S089) | Boston Scientific Corporation | 2025-04-02 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT (P060022/S034) | Bausch & Lomb, Inc. | 2025-04-02 |
| Cobalt MRI ICD DVPB3D4 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1 Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4 Cobalt XT MR (P980016/S920) | Medtronic Cardiac Rhythm Disease Management | 2025-04-02 |
| HeartWare HVAD System (P100047/S224) | Medtronic | 2025-04-02 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S198) | ABBOTT MEDICAL | 2025-04-01 |
| Coaptite (P040047/S076) | Merz North America, Inc. | 2025-04-01 |
| Sprint Quattro Lead (P920015/S298) | Medtronic, Inc. | 2025-04-01 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent (P910023/S461) | ABBOTT MEDICAL | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| SelectSecure Lead (P030036/S152) | Medtronic Cardiac Rhythm Disease Management | 2025-04-01 |
| JUVEDERM VOLUMA XC (P110033/S095) | Allergan | 2025-04-01 |
| JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS (P050047/S102) | Allergan | 2025-04-01 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S032) | Corcym S.r.l. | 2025-04-01 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S084) | ABBOTT MEDICAL | 2025-04-01 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S416) | ABBOTT MEDICAL | 2025-04-01 |
| Microny family of Pacemakers (P970013/S094) | ABBOTT MEDICAL | 2025-04-01 |
| RADIESSE Injectable Implant; RADIESSE Hands; RADIESSE (+) Lidocaine (P050052/S167) | Merz North America, Inc. | 2025-04-01 |
| RADIESSE Injectable Implant (P050037/S143) | Merz North America, Inc. | 2025-04-01 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S333) | ABBOTT MEDICAL | 2025-04-01 |
| HEMOBLAST Bellows (P170012/S030) | Dilon Technologies, Inc. | 2025-03-31 |
| T-SPOT TB (P070006/S024) | Oxford Immunotec, Ltd. | 2025-03-31 |