510(k) Clearances — Page 36

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 36 of 3,525)
ClearancesDetails
K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCS Mar 24, 2026
K260202 — LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd. Mar 23, 2026
K254166 — MDx-Chex for BCNStreck Mar 23, 2026
K252992 — CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. Mar 23, 2026
K252031 — Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd. Mar 23, 2026
K260112 — QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. Mar 23, 2026
K254288 — Clavicle Fixation SystemSkeletal Dynamics, Inc. Mar 23, 2026
K253686 — True Definition DLGe Healthcare Japan Corporation Mar 23, 2026
K254275 — HyperSuture All Green Extension LineThreadstone, LLC Mar 23, 2026
K253604 — TiLink-L Navigation InstrumentsSurGenTec, LLC Mar 20, 2026
K253849 — Electric wheelchair (JJW-7002, JJW-7003)ZheJiang J&J Mobility Co., Ltd. Mar 20, 2026
K252358 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj Mar 20, 2026
K251950 — Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)Hangzhou Tappa Medical Technology Co., Ltd. Mar 20, 2026
K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd. Mar 20, 2026
K251980 — ClaveQS™ BagIcu Medical, Inc. Mar 20, 2026
K252606 — Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH Mar 20, 2026
K253520 — Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC Mar 20, 2026
K260437 — Valvuloplasty Balloon Catheter (ValvuloPro)Dongguan TT Medical, Inc. Mar 20, 2026
K253574 — SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc. Mar 20, 2026
K254170 — Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd. Mar 20, 2026
K253864 — NOMAD Pro 3Dental Imaging Technologies Corporation Mar 20, 2026
K251937 — nordicAudio (1.0)Nordicneurolab AS Mar 20, 2026
K254208 — FLOWRUNNER Aspiration SystemExpanse Medical, Inc. Mar 20, 2026
K260551 — HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co. Mar 20, 2026
K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation Mar 20, 2026
K260561 — Arthrex FiberTak Suture AnchorArthrex, Inc. Mar 20, 2026
K252016 — Arthrex Humeral NailsArthrex, Inc. Mar 20, 2026
K253098 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj Mar 20, 2026
K260585 — Noxturnal WebNox Medical Ehf Mar 20, 2026
K252005 — Livi DeviceLiviwell, Inc. Mar 20, 2026
K260519 — Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd. Mar 20, 2026
K260537 — Willow 24 GuidewireArbor Endovascular, LLC Mar 19, 2026
K253432 — DiversiVy™ Facet Screw SystemVy Spine, LLC Mar 19, 2026
K254112 — Dia-X Sil BiteDiaDent Group International Mar 19, 2026
K253746 — Enroute 0.014'' Transcarotid GuidewireLake Region Medical Mar 19, 2026
K252101 — JWG-1Yamaha Motor Co., Ltd. Mar 19, 2026
K260532 — Derma-GideGeistlich Pharma AG Mar 19, 2026
K260533 — ELISIO™-HNipro Medical Corporation Mar 19, 2026
K260448 — CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. Mar 19, 2026
K253139 — Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd. Mar 19, 2026
K253965 — CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd. Mar 19, 2026
K260509 — AutoContour (RADAC V5)Radformation, Inc. Mar 19, 2026
K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. Shine Optical Co., Ltd. Mar 19, 2026
K254110 — DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc. Mar 18, 2026
K253622 — Safety Pen NeedleNingbo Medsun Medical Co., Ltd. Mar 18, 2026
K253834 — VISUREF 600Carl Zeiss Vision GmbH Mar 18, 2026
K252304 — syngo.via RT Image Suite VC10Varian Medical Systems, Inc. Mar 18, 2026
K253444 — EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC Mar 18, 2026
K253012 — AlignRT Plus (8.0)Vision Rt, Ltd. Mar 18, 2026
K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc. Mar 18, 2026
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