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

MQL 2026-02-20

CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)

Applicant Casebioscience, Inc.

K-Number K252672

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FMK 2026-02-20

Safety Heel Lancet

Applicant Ningbo Medsun Medical Co., Ltd.

K-Number K253605

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OBP 2026-02-20

SPRY TMS Therapy System (0550)

Applicant Soterix Medical, Inc.

K-Number K251653

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HRS 2026-02-20

KLS Martin Pure Pectus System

Applicant KLS-Martin L.P.

K-Number K253660

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N/A 2026-02-20

Xpert Hemorrhagic Fever

Applicant Cepheid

K-Number K253653

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HRS 2026-02-20

KLS Martin Ixos System

Applicant KLS Martin L.P.

K-Number K254162

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DQK 2026-02-20

CARTO 3 EP Navigation System V8.4

Applicant Biosense Webster, Inc.

K-Number K252972

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OHS 2026-02-20

FAQ (LED Panel); FAQ (Dual LED Panel)

Applicant Foreo, Inc.

K-Number K253683

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FQH 2026-02-20

BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)

Applicant Bd

K-Number K253445

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JFY 2026-02-20

QSCHECK UISACR

Applicant Qstag, Inc.

K-Number K252619

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OLO 2026-02-20

POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set

Applicant Point Robotics MedTech, Inc.

K-Number K252989

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FAD 2026-02-20

Disposable Ureteral Stents

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K251890

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