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

QKB 2026-01-23

AccuContour 4.0

Applicant Manteia Technologies Co., Ltd.

K-Number K251351

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QAJ 2026-01-23

Elitone for Men

Applicant Elidah, Inc.

K-Number K253285

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NEU 2026-01-23

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

Applicant Devicor Medical Products, Inc.

K-Number K253761

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FRO 2026-01-23

New Day Skin Spray

Applicant Silk Holdings, Inc.

K-Number K252568

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MAX 2026-01-23

Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

Applicant Life Spine, Inc.

K-Number K253748

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DJG 2026-01-23

Evidence MultiSTAT DOA Urine MultiPlex

Applicant Randox Laboratories Limited

K-Number K250741

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OHS 2026-01-23

LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

Applicant Shenzhen Rainbow Technology Co., Ltd.

K-Number K253712

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NHA 2026-01-22

Straumann Variobase Abutments XC for Bridge/Bar

Applicant Institut Straumann AG

K-Number K253315

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PPU 2026-01-22

PhenoMATRIX

Applicant Copan Wasp Srl

K-Number K251511

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DYB 2026-01-22

Genie MAX Large Bore Introducer Sheath

Applicant Cultiv8 1, LLC

K-Number K253652

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PML 2026-01-22

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Applicant Astura Medical

K-Number K252885

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HGX 2026-01-22

Pump In Style® Pro+

Applicant Medela, LLC

K-Number K253498

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