| PD-L1 IHC 22C3 pharmDx (Dako Omnis) (P150013/S028) | Agilent Technologies, Inc. | 2025-08-04 |
| Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); (P030054/S438) | ABBOTT MEDICAL | 2025-08-04 |
| IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc) (P010051/S023) | Siemens Healthcare Diagnostics Products, Ltd. | 2025-08-04 |
| Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; (P140003/S123) | Abiomed, Inc. | 2025-08-01 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| AFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG) (P240013/S008) | Medtronic, Inc. | 2025-08-01 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S020) | ABBOTT MEDICAL | 2025-08-01 |
| InterStim Therapy System, Verify Evaluation System (P080025/S326) | Medtronic Neuromodulation | 2025-08-01 |
| InterStim Therapy System, Verify Evaluation System (P970004/S431) | Medtronic Neuromodulation | 2025-08-01 |
| AngioJet Thrombectomy System (P980037/S095) | Boston Scientific Corp | 2025-08-01 |
| Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System; (P170011/S056) | Abiomed, Inc. | 2025-08-01 |
| CINtec PLUS Cytology (P190024/S014) | Ventana Medical Systems, Inc. | 2025-07-31 |
| Biomedics 55 Asphere; Biomedics Toric (P890023/S055) | The Cooper Companies | 2025-07-31 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S030) | CooperVision, Inc. | 2025-07-30 |
| prodisc L (P050010/S028) | Centinel Spine, LLC | 2025-07-30 |
| Thoraflex Hybrid (P210006/S013) | Vascutek, Ltd. | 2025-07-30 |
| SetPoint System (P240039) | SetPoint Medical | 2025-07-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S003) | Bausch & Lomb, Inc. | 2025-07-30 |
| prodisc® C (P070001/S029) | Centinel Spine, LLC | 2025-07-30 |
| Epic Plus Stented Tissue Valve; Epic Max Stented Tissue Valve (P040021/S059) | ABBOTT MEDICAL | 2025-07-29 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S213) | Medtronic, Inc. | 2025-07-29 |
| Aurora EV-ICD System (P220012/S055) | Medtronic, Inc. | 2025-07-29 |
| Evera MRI DF-1 ICD (DDMB1D1, DVMB1D1, DVMC3D1); Evera MRI DF-1 ICD(DDMC3D1); Evera MRI ICD (DDMB1D4); Evera MRI ICD (DDM (P980016/S933) | Medtronic Cardiac Rhythm Disease Management | 2025-07-29 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S899) | Medtronic Cardiac Rhythm Disease Management | 2025-07-29 |
| Model A71100 Restore Clinician Programmer Application (CPA) and Model A71200 Vanta/Sequentia LT Clinician Programmer A (P840001/S594) | Medtronic Neuromodulation | 2025-07-29 |
| Tendyne Transcatheter Mitral Valve (P240042/S001) | ABBOTT MEDICAL | 2025-07-29 |
| Navitor Transcatheter Aortic Valve (P190023/S026) | ABBOTT MEDICAL | 2025-07-29 |
| Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap (P980035/S819) | Medtronic, Inc. | 2025-07-29 |
| InterStim Therapy System; Verify Evaluation System (P970004/S430) | Medtronic Neuromodulation | 2025-07-28 |
| InterStim Therapy System; Verify Evaluation System (P080025/S325) | Medtronic Neuromodulation | 2025-07-28 |
| Liberta RC DBS IPG (Model 62400) (P140009/S118) | ABBOTT MEDICAL | 2025-07-28 |
| CardioMEMS HF System (P100045/S083) | ABBOTT MEDICAL | 2025-07-28 |
| Stylets Models 6053, 6054, 6055 (P960004/S107) | Boston Scientific | 2025-07-28 |
| Eterna SCS IPG (Model 32400) (P010032/S236) | ABBOTT MEDICAL | 2025-07-28 |
| LifePulse High Frequency Ventilator (HFV) (P850064/S055) | Bunnell, Inc. | 2025-07-25 |
| Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (P170011/S059) | Abiomed, Inc. | 2025-07-25 |
| 4Kscore Test (P190022/S003) | Opko Health, Inc. | 2025-07-25 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S068) | Alcon Research, Ltd. | 2025-07-25 |
| Protege RX Carotid Stent System; Protege GPS Self-Expanding Peripheral Stent System (P060001/S050) | Medtronic Vascular, Inc. | 2025-07-25 |
| EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S060) | Medtronic Vascular, Inc. | 2025-07-25 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S012) | ABBOTT MEDICAL | 2025-07-25 |
| VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Ophthalmic Viscosurgical Device (P840064/S090) | Alcon Laboratories | 2025-07-25 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (P140003/S128) | Abiomed, Inc. | 2025-07-25 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S024) | Edwards Lifesciences, LLC | 2025-07-25 |
| Cologuard Plus (P230043/S002) | Exact Sciences Corporation | 2025-07-24 |
| AED Plus and Fully Automatic AED Plus (P160015/S024) | ZOLL Medical Corporation | 2025-07-24 |
| Sientra Silicone Gel Breast Implants (P070004/S047) | Tiger Aesthetics Medical, LLC | 2025-07-24 |
| Nucleus® 24 Cochlear Implant System (P970051/S234) | Cochlear Americas | 2025-07-24 |
| Cologuard® test (P130017/S064) | Exact Sciences Corporation | 2025-07-24 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S052) | Berlin Heart, Inc. | 2025-07-24 |
| Quest Diagnostics AAVrh74 Antibody ELISA CDx (P250002) | Quest Diagnostics Nichols Institute | 2025-07-24 |
| Shield (P230009/S007) | Guardant Health, Inc. | 2025-07-23 |
| MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR (P890057/S029) | ZOLL Medical Corporation | 2025-07-23 |
| Edwards EVOQUE tricuspid delivery system (P230013/S017) | Edwards Lifesciences, LLC | 2025-07-23 |
| Proclaim DRG IPG (P150004/S087) | ABBOTT MEDICAL | 2025-07-23 |
| MynxGrip Vascular Closure Device (5F, 6F/7F); Mynx Control Vascular Closure Device (5F, 6F/7F); Mynx Control Venous Vasc (P040044/S110) | Cordis US Corporation | 2025-07-23 |
| VEGA R45; VEGA R52; VEGA R58; VEGA R45 RE-INTERVENTION KIT; VEGA R58 RE-INTERVENTION KIT; VEGA R45 RE-INTERVENTION KIT (P130010/S004) | MicroPort CRM USA, Inc. | 2025-07-23 |
| HexaFlow Irrigation Pumo AFR-00004, HexaGen TM RF Generator AFR-00005, HexaPulse TM PF Generator AFR-00008 (P240013/S014) | Medtronic, Inc. | 2025-07-23 |
| Platinium VR 1210, Platinium VR 1240, ENERGYA VR 3110, TALENTIA VR 3210, ENERGYA VR 3140, TALENTIA VR 3240, Platinium DR (P980049/S147) | MicroPort CRM USA, Inc. | 2025-07-23 |
| Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids (P040003/S022) | Insightec, Ltd. | 2025-07-23 |
| VARIPULSE Platform (P240006/S009) | Biosense Webster, Inc. | 2025-07-23 |
| Platinium CRT-D 1711; Platinium CRT-D 1741; Platinium 4LV CRT-D 1744; ENERGYA CRT-D 3711; ENERGYA CRT-D 3741; ENERGYA 4L (P060027/S107) | MicroPort CRM USA, Inc. | 2025-07-23 |
| MitraClip G5 Delivery System (P100009/S077) | ABBOTT MEDICAL | 2025-07-23 |
| Reply SR; Reply DR; ALIZEA SR 1300; ALIZEA DR 1600; CELEA SR 1100; CELEA DR 1400 (P950029/S134) | MicroPort CRM USA, Inc. | 2025-07-23 |
| up&up Monthly Performance, up&up Monthly Performance XR, up&up Monthly Performance for Astigmatism, up&up Monthly Perfor (P080011/S180) | CooperVision, Inc. | 2025-07-23 |
| TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System (P980052/S016) | Stryker Leibinger, GmbH & Co KG | 2025-07-23 |
| TECNIS Odyssey Toric II IOL with TECNIS SIMPLICITY Delivery System, Model DRT (P980040/S175) | Johnson & Johnson Surgical Vision, Inc. | 2025-07-22 |
| RelayPro Thoracic Stent-Graft System (P200045/S016) | Bolton Medical, Inc. | 2025-07-22 |
| TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 (P990080/S063) | Johnson & Johnson Surgical Vision, Inc. | 2025-07-22 |
| Sphere-9 Catheter and Affera Ablation System (HexaFlow Irrigation Pump; HexaGen RF Generator; HexaPulse PF Generator) (P240013/S012) | Medtronic, Inc. | 2025-07-22 |
| Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, (P840001/S601) | Medtronic Neuromodulation | 2025-07-22 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S024) | Abbott Vascular, Inc. | 2025-07-22 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S017) | Kestra Medical Technologies, Inc. | 2025-07-22 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S513) | Medtronic, Inc. | 2025-07-22 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S036) | Bausch & Lomb, Inc. | 2025-07-22 |
| TECNIS 3-Piece Multifocal, Model ZMA00 (P080010/S028) | Johnson & Johnson Surgical Vision, Inc. | 2025-07-22 |
| SUPARTZ FX; VISCO-3 (P980044/S063) | Seikagaku Corp. | 2025-07-22 |
| 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT (P110015/S011) | Advanced Breath Diagnostics | 2025-07-21 |
| MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG) (P130008/S127) | Inspire Medical Systems | 2025-07-21 |
| SURGIFLO® Hemostatic Matrix; SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S075) | Ferrosan Meidcal Devices A/S | 2025-07-18 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S341) | Depuy, Inc. | 2025-07-18 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S051) | Berlin Heart, Inc. | 2025-07-18 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, (P190018/S042) | Alcon Laboratories, LLC | 2025-07-18 |
| EndoForce Connector for Endovascular Venous Anastomosis (P240004/S001) | Phraxis, Inc. | 2025-07-18 |
| OrganOx metra® System (P200035/S027) | Organox Limited | 2025-07-18 |
| Cologuard Plus (P230043/S001) | Exact Sciences Corporation | 2025-07-18 |
| Cologuard® (P130017/S063) | Exact Sciences Corporation | 2025-07-18 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S510) | Medtronic, Inc. | 2025-07-17 |
| HeartMate II Left Ventricular Assist System (P060040/S120) | ABBOTT MEDICAL | 2025-07-17 |
| Protégé RX Carotid Stent System (P060001/S049) | Medtronic Vascular, Inc. | 2025-07-17 |
| InterStim Therapy System, Verify Evaluation System (P080025/S324) | Medtronic Neuromodulation | 2025-07-17 |
| Master Restore, Itrel®, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify®, a (P840001/S598) | Medtronic Neuromodulation | 2025-07-17 |
| Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Spe (P840001/S599) | Medtronic Neuromodulation | 2025-07-17 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S511) | Medtronic, Inc. | 2025-07-17 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S427) | Medtronic Neuromodulation | 2025-07-17 |
| InterStim Therapy System, Verify Evaluation System (P970004/S428) | Medtronic Neuromodulation | 2025-07-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S109) | ABBOTT MEDICAL | 2025-07-17 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S446) | Medtronic, Inc. | 2025-07-17 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S445) | Medtronic, Inc. | 2025-07-17 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S322) | Medtronic Neuromodulation | 2025-07-17 |