Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MBI 2026-01-06

QuadLock Fixation System

Applicant Abanza Tecnomed S.L

K-Number K253618

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HRS 2026-01-06

TRILEAP Plating System

Applicant Crossroads Extremity Systems

K-Number K253178

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FMI 2026-01-06

Pen Needle

Applicant Hh Global Technology, Inc.

K-Number K252886

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PAY 2026-01-06

Sensilift Pro (ST300XXYYZZZ)

Applicant El Global Trade, Ltd.

K-Number K250341

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SGR 2026-01-06

Saans (F4-01-00-000-000)

Applicant Innaccel Technologies Private Limited

K-Number K251165

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PDJ 2026-01-06

Medconn 8K Glycated Hemoglobin Test System

Applicant Shanghai Medconn Medical Technology Co., Ltd.

K-Number K252749

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JWH 2026-01-06

Materialise TKA Guide System

Applicant Materialise NV

K-Number K253793

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FXX 2026-01-05

Disposable Medical Face Mask

Applicant Makrite Industries, Inc.

K-Number K252650

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IYE 2026-01-05

ChartCheck (RADCH V1.6)

Applicant Radformation, Inc.

K-Number K252988

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QJP 2026-01-05

SurfRider 13 Microcatheter

Applicant Kaneka Americas Holding, Inc.

K-Number K251668

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IYN 2026-01-05

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K252018

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LLZ 2026-01-05

maiLink

Applicant Maihub Corp.

K-Number K253008

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