510(k) Clearances in 2025 — Page 65

3,225 510(k) clearances total

Browse FDA 510(k) clearances granted in 2025. RegDataLab tracks 3,225 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2025 (page 65 of 65)
510(k) clearancesDetails
K242753 — SD TL Implant SystemArum Dentistry Co., Ltd. Jan 6, 2025
K242139 — Mobility Scooter (YL-09B, YL-07)Yongkang Yile Vehicle Co., Ltd. Jan 6, 2025
K241350 — Clarify DLGe Medical Systems Israel, Functional Imaging Jan 3, 2025
K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point Of Care, Inc. Jan 3, 2025
K242578 — EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC Jan 3, 2025
K241283 — Elemental GranulateZinkh NV Jan 3, 2025
K243737 — Inbella RF SystemInbella Medical, Inc. Jan 3, 2025
K250015 — Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation Jan 3, 2025
K241757 — syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. Jan 3, 2025
K242119 — INNOVISION-EXIIDk Medical System Jan 3, 2025
K240346 — NobelProcera Zirconia Implant BridgeNobel Biocare AB Jan 3, 2025
K233419 — GBR SystemProimtech Saglik Urunleri Anonim Sirketi Jan 3, 2025
K243363 — JLK-ICHJLK, Inc. Jan 3, 2025
K233118 — DUET-V (Model: ESK-3261DV)Eunsung Global Corp Jan 3, 2025
K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax Of America, Inc. Jan 3, 2025
K242726 — Synapsys VHITInventis S.R.L. Jan 3, 2025
K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl Jan 2, 2025
K242789 — Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd. Jan 2, 2025
K242448 — Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)Anhui Jbh Medical Apparatus Co., Ltd. Jan 2, 2025
K241568 — CrystLCare™ PRO Biorestorative, Fluoride-PlusGreenMark Biomedical, Inc. Jan 2, 2025
K241005 — Haemostasis ClipsJiangxi Zhuoruihua Medical Instrument Co., Ltd. Jan 2, 2025
K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective CatheterMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jan 2, 2025
K242334 — Ezra FlashEzra Ai, Inc. Jan 2, 2025
K243049 — Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. Jan 2, 2025
K241696 — Ortho AIOrtho Ai, LLC Jan 2, 2025
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