| K251767 — Vena MicroAngioscope System | Vena Medical Holdings Corp Oct 1, 2025 |
| K250083 — PRO-DOSE System | Nu-Rise, SA Oct 1, 2025 |
| K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Shenzhen Ulike Smart Electronics Co., Ltd. Oct 1, 2025 |
| K251899 — E Blator | New Deantronics Taiwan , Ltd. Oct 1, 2025 |
| K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | Shenzhen Ulike Smart Electronics Co., Ltd. Oct 1, 2025 |
| K250767 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Oct 1, 2025 |
| K252106 — External Fixation Mini Rail System | Paragon 28, Inc. Sep 30, 2025 |
| K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. Sep 30, 2025 |
| K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) Sep 30, 2025 |
| K251690 — Arthrex SpeedFLEX Implant | Arthrex, Inc. Sep 30, 2025 |
| K250050 — miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV Sep 30, 2025 |
| K252072 — Francisella tularensis Real-time PCR assay | Centers For Disease Control And Prevention Sep 30, 2025 |
| K251799 — Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) | Jiangsu Bangbang Intelligent Technology Co., Ltd. Sep 30, 2025 |
| K243270 — TigerConnect Alarm Management | Tigerconnect Sep 30, 2025 |
| K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. Sep 30, 2025 |
| K251197 — Dexter L6 System | Distalmotion SA Sep 30, 2025 |
| K252722 — Biopsy Forceps | Fehling Instruments GmbH Sep 30, 2025 |
| K250023 — SMART PCFD | Disior, Ltd. Sep 29, 2025 |
| K252594 — UltraGuideCTR® image guided soft tissue release system | Sonex Health Sep 29, 2025 |
| K252054 — SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. Sep 29, 2025 |
| K243833 — Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. Sep 29, 2025 |
| K251104 — SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical Sep 29, 2025 |
| K251334 — NEW DOUBLO 2.0 | Hironic Co., Ltd. Sep 29, 2025 |
| K243983 — Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. Sep 29, 2025 |
| K252051 — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. Sep 29, 2025 |
| K252770 — iLet ACE Pump | Beta Bionics, Inc. Sep 29, 2025 |
| K252441 — Primero Safe Access System | South53, LLC Sep 29, 2025 |
| K253236 — G-BLOCK | Graphenano Dental S.L. Sep 29, 2025 |
| K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH Sep 29, 2025 |
| K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation Sep 26, 2025 |
| K252221 — Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. Sep 26, 2025 |
| K251275 — VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical Sep 26, 2025 |
| K251919 — Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co., Ltd. Sep 26, 2025 |
| K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. Sep 26, 2025 |
| K252435 — Magnetic Surgical System | Levita Magnetics International Corp Sep 26, 2025 |
| K252105 — Ligence Heart | Ligence Uab Sep 26, 2025 |
| K252700 — Optima Coil System (Optima Packing Coil System) | Balt USA, LLC Sep 26, 2025 |
| K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation Sep 26, 2025 |
| K251208 — Tuned Self-Fitting Mobile App | Tuned , Ltd. Sep 26, 2025 |
| K251262 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Sep 26, 2025 |
| K251204 — FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation Sep 26, 2025 |
| K250318 — Planmed XFI | Planmed OY Sep 26, 2025 |
| K251986 — AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation Sep 26, 2025 |
| K250659 — LoFric Origo | Wellspect AB Sep 26, 2025 |
| K251148 — JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl Sep 25, 2025 |
| K252063 — Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | Wuhan Dimed Laser Technology Co., Ltd. Sep 25, 2025 |
| K251997 — Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation Sep 25, 2025 |
| K252371 — uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. Sep 25, 2025 |
| K252013 — EnSite X EP System | ABBOTT MEDICAL Sep 25, 2025 |
| K250837 — Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. Sep 25, 2025 |