| K261808 — ISAAC Neurovascular Navigation Catheter | Microvention Inc. D/B/A Terumo Neuro Jun 30, 2026 |
| K262195 — Dandy Ceramic Stain and Glaze | Zima International Inc., Dba Dandy Jun 30, 2026 |
| K260576 — MeVis AVM Contour | MeVis Medical Solutions AG Jun 30, 2026 |
| K253767 — UB ERP System | Universal Brain Jun 30, 2026 |
| K261101 — Ceribell Monitor | Ceribell, Inc. Jun 30, 2026 |
| K261068 — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical Jun 30, 2026 |
| K261415 — Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. Jun 29, 2026 |
| K253628 — Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. Jun 29, 2026 |
| K251492 — Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. Jun 29, 2026 |
| K261461 — Omnipod 6 algorithm | Insulet Corporation Jun 29, 2026 |
| K260667 — Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Jun 29, 2026 |
| K261481 — Pangea Femur Reconstruction System | Stryker GmbH Jun 29, 2026 |
| K253969 — ADAS 3D | Adas3D Medical S.L. Jun 29, 2026 |
| K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | Sterilmed, Inc. Jun 29, 2026 |
| K261052 — LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. Jun 29, 2026 |
| K253484 — LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation Jun 29, 2026 |
| K260918 — Zolid Lunaris | Amann Girrbach AG Jun 29, 2026 |
| K253301 — BraiN20® (BraiN20) | Time IS Brain, S.L. Jun 27, 2026 |
| K261122 — MIST IC | Imagine Milling Technologies, LLC Jun 27, 2026 |
| K253390 — SOMNUM (SOMNUM) | Honeynaps Co., Ltd. Jun 27, 2026 |
| K261745 — LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical Jun 26, 2026 |
| K261455 — Arterial Pressure Monitoring Set/Tray | Spectrum Vascular Jun 26, 2026 |
| K260018 — Arthrex FiberButton | Arthrex, Inc. Jun 26, 2026 |
| K261253 — Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | Ziree Co., Ltd. Jun 26, 2026 |
| K253921 — VERTICALE® Navigation Instruments | Silony Medical GmbH Jun 26, 2026 |
| K261351 — SALGINA 2.5mm Distal Radius System | Bonebridge AG Jun 26, 2026 |
| K253306 — BioTracker 2.0 | Biotracker, LLC Jun 26, 2026 |
| K253316 — PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. Jun 26, 2026 |
| K261039 — i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. Jun 26, 2026 |
| K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | Edwards Lifesciences Jun 26, 2026 |
| K260061 — BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. Jun 26, 2026 |
| K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. Jun 26, 2026 |
| K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. Jun 26, 2026 |
| K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. Jun 26, 2026 |
| K260714 — MammoScreen® (5) | Therapixel Jun 26, 2026 |
| K261025 — Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. Jun 25, 2026 |
| K260709 — ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | Longeviti Neuro Solutions Jun 25, 2026 |
| K253216 — IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. Jun 25, 2026 |
| K253384 — mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. Jun 25, 2026 |
| K251188 — UNIQA® Dental Implants System | Uniqa Dental, Ltd. Jun 25, 2026 |
| K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. Jun 25, 2026 |
| K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. Jun 25, 2026 |
| K260231 — MiPACS V5 (1.0.0) | Apryse Software Corp Jun 25, 2026 |
| K260480 — VELYS Robotic-Assisted Solution | Depuy Ireland UC Jun 25, 2026 |
| K253367 — EliA CTD 13 Screen | Phadia AB Jun 25, 2026 |
| K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. Jun 25, 2026 |
| K261242 — SimplGuide | Pendracare Jun 25, 2026 |
| K253786 — syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. Jun 25, 2026 |
| K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 25, 2026 |
| K253386 — DVT Garment | Vistar Medical Supplies Co., Ltd. Jun 25, 2026 |