Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

HRS 2026-03-19

CastleLoc Pectus Bar System

Applicant L&K BIOMED Co., Ltd.

K-Number K260448

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KDI 2026-03-19

ELISIO™-H

Applicant Nipro Medical Corporation

K-Number K260533

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ILY 2026-03-19

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

Applicant Wuhan PHOMED Technology Company , Ltd.

K-Number K253965

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ELW 2026-03-19

Dia-X Sil Bite

Applicant DiaDent Group International

K-Number K254112

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MOF 2026-03-19

Willow 24 Guidewire

Applicant Arbor Endovascular, LLC

K-Number K260537

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ITI 2026-03-19

JWG-1

Applicant Yamaha Motor Co., Ltd.

K-Number K252101

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OLO 2026-03-18

EUROPA™ Posterior Cervical Fusion Navigated Instruments

Applicant MiRus, LLC

K-Number K253444

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HWC 2026-03-18

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro

Applicant MedShape, Inc.

K-Number K254110

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FXX 2026-03-18

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 Visor

Applicant O&M Halyard, Inc.

K-Number K251967

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FMI 2026-03-18

Safety Pen Needle

Applicant Ningbo Medsun Medical Co., Ltd.

K-Number K253622

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IYE 2026-03-18

AlignRT Plus (8.0)

Applicant Vision Rt, Ltd.

K-Number K253012

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HSB 2026-03-18

Fusion FibFix Nail

Applicant Fusion Orthopedics USA, LLC

K-Number K252961

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