510(k) Clearances — Page 48

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 48 of 3,525)
ClearancesDetails
K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd. Jan 12, 2026
K251524 — Dr. Yglo Skin Tag RemoverTheotclab Healthcare B.V. Jan 12, 2026
K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd. Jan 12, 2026
K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc. Jan 12, 2026
K251701 — Star E900 Electric SystemDentalez, Inc., Stardental Division Jan 12, 2026
K251886 — EmpowerRide NAVIGATOREmpower Ride, LLC Jan 12, 2026
K252830 — Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd. Jan 12, 2026
K252913 — Break WaveSonomotion, Inc. Jan 12, 2026
K251988 — Boston iFace (Boston iFace)Boston Aesthetics, Inc. Jan 12, 2026
K252962 — DYNAMIS™ Navigation SystemPromethean Restorative, LLC Jan 12, 2026
K250890 — SBC1 CreamSioxmed, LLC Jan 12, 2026
K251558 — Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. Jan 12, 2026
K253167 — Any-PasteMediclus Co., Ltd. Jan 12, 2026
K252842 — SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. Jan 11, 2026
K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)Ningbo Ranor Medical Technology Co., Ltd. Jan 9, 2026
K252339 — iotaSOFT® Insertion SystemIotamotion, Inc. Jan 9, 2026
K252847 — NextAR Hip PlatformMedacta International S.A. Jan 9, 2026
K254003 — JARVIS Metaphyseal StemFH Industrie Jan 9, 2026
K252674 — Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. Jan 9, 2026
K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC Jan 9, 2026
K253957 — HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co. Jan 9, 2026
K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc. Jan 9, 2026
K251139 — KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG Jan 9, 2026
K252589 — Corvair MonzaAliveCor, Inc. Jan 9, 2026
K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP SeriesLiaoning Upcera Co., Ltd. Jan 9, 2026
K253550 — Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. Jan 9, 2026
K251157 — Core MetabolicTruvian Health Jan 9, 2026
K253075 — Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Jan 9, 2026
K252206 — Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation Jan 9, 2026
K253639 — ViewGE Healthcare Jan 8, 2026
K253370 — LOGIQ TotusGE Medical Systems Ultrasound And Primary Care Diagnostics Jan 8, 2026
K252669 — Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory Jan 8, 2026
K252585 — ZENEX Implant System_R-SystemIzenimplant Co., Ltd. Jan 8, 2026
K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd. Jan 8, 2026
K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies Jan 8, 2026
K253266 — Titanium Interbody SystemSpine Innovation, LLC Jan 8, 2026
K253512 — MiniMed Go AppMedtronic Minimed Jan 8, 2026
K252759 — revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc. Jan 8, 2026
K252794 — Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc. Jan 8, 2026
K253784 — 3DICOM MD CloudSingular Health Pty, Ltd. Jan 8, 2026
K252788 — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. Jan 8, 2026
K251207 — Sangria™ Thrombectomy SystemAvantec Vascular Corporation Jan 7, 2026
K250305 — Reprocessed Agilis NxT Steerable IntroducerInnovative Health Jan 7, 2026
K253366 — LOGIQ FortisGE Medical Systems Ultrasound And Primary Care Diagnostics Jan 7, 2026
K252727 — Neodent InLab Validated WorkflowJJGC Indústria E Comércio De Materiais Dentários S.A. Jan 7, 2026
K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc. Jan 7, 2026
K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd. Jan 7, 2026
K253939 — DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc. Jan 7, 2026
K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsMaterialise NV Jan 7, 2026
K253924 — PuraStat3-D Matrix Europe SAS Jan 7, 2026
← Previous Page 48 of 3525 Next →