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

GEX 2026-05-04

Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)

Applicant Leaseir Technologies, Slu

K-Number K253251

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SHW 2026-05-04

ArteraAI Breast

Applicant Artera, Inc.

K-Number K254115

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FPA 2026-05-04

AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

Applicant Amsino International, Inc.

K-Number K252543

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OLI 2026-05-04

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K260688

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LLZ 2026-05-04

Neowise

Applicant Cefla S.C.

K-Number K260716

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HIS 2026-05-04

Male Latex Condom HA

Applicant Okamoto USA, Inc.

K-Number K252622

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QFM 2026-05-04

MammoSightAI

Applicant Neurocareai, Inc. (Dba Savelife.Ai)

K-Number K252954

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GEX 2026-05-04

Q-Switched Nd: YAG Laser Systems

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K260256

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MXD 2026-05-01

BIOMONITOR IV (471155)

Applicant Biotronik, Inc.

K-Number K261074

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LBH 2026-05-01

VOCO Profluorid Varnish + BioMin

Applicant Voco GmbH

K-Number K252073

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NKB 2026-05-01

PERLA® TL Posterior Thoraco-lumbar Fixation System

Applicant Spineart SA

K-Number K253966

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GXY 2026-05-01

Tutamen Self Adhesive Electrodes

Applicant Dongguan Tutamen Metalwork Co., Ltd.

K-Number K252439

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