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

KGW 2026-02-23

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

Applicant Applied Medical Resources Corporation

K-Number K253531

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KLE 2026-02-23

VITA VMLC Primer

Applicant Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

K-Number K251587

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FDT 2026-02-22

Single Use Distal Cover MAJ-2315 (MAJ-2315)

Applicant Olympus Medical Systems Corp.

K-Number K253646

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FDI 2026-02-21

Advanced Tissue Resection Device

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K251692

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OWB 2026-02-20

CARA System

Applicant Cara Medical, Ltd.

K-Number K252500

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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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