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

MUJ 2025-12-22

RayStation (2024A SP3)

Applicant RaySearch Laboratories AB (PUBL)

K-Number K252109

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HTN 2025-12-22

Syndesmosis TightRope PRO

Applicant Arthrex, Inc.

K-Number K253727

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PKP 2025-12-22

Tetra (TM-20); Tetra (TM-50)

Applicant Emed Technologies Corporation

K-Number K251105

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OVE 2025-12-22

HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)

Applicant Globus Medical, Inc.

K-Number K253876

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DPS 2025-12-22

AccurECG Analysis System (v2.0)

Applicant Accurkardia, Inc.

K-Number K252361

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LEL 2025-12-22

EmbraceMini

Applicant Empatica S.r.l.

K-Number K252981

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DZE 2025-12-22

DIMPLO Implant System

Applicant DIMPLO, Ltd.

K-Number K251605

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KGN 2025-12-22

LacertaMatrix

Applicant Lacerta Life Science

K-Number K252673

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GAM 2025-12-22

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

Applicant ETHICON, Inc.

K-Number K252743

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ITI 2025-12-22

Power wheelchair

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K251159

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FGE 2025-12-22

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

Applicant Bioteque Corporation

K-Number K251019

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OWB 2025-12-22

MC2 Portable X-ray System

Applicant Oxos Medical

K-Number K252068

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