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

HBE 2025-09-19

UniBur

Applicant Nakanishi, Inc.

K-Number K252662

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QYE 2025-09-19

Bunkerhill ECG-EF

Applicant BunkerHill Health

K-Number K250649

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SFS 2025-09-19

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

Applicant Cytocell Limited

K-Number DEN240067

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HGM 2025-09-19

Sonicaid Team3

Applicant Huntleigh Healthcare , Ltd.

K-Number K250777

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LZO 2025-09-19

Coated hip implants

Applicant Medacta International S.A.

K-Number K250450

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HEB 2025-09-19

Unscented menstrual three-piece applicator tampon

Applicant Unibeauty (Hubei) Technology Co., Ltd.

K-Number K252613

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GEX 2025-09-19

IPGTFL-02

Applicant Ipg Medical Corporation

K-Number K251100

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GEX 2025-09-19

VEGA

Applicant Ibramed Equipamentos Médicos

K-Number K242859

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OWY 2025-09-19

Tapestry Biointegrative Implant

Applicant Embody, Inc.

K-Number K252647

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FDT 2025-09-19

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)

Applicant Olympus Medical Systems Corp.

K-Number K251867

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LLL 2025-09-19

Alegria Flash ENA Screen

Applicant Zeus Scientific

K-Number K250408

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ELC 2025-09-19

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

Applicant Nakanishi, Inc.

K-Number K251689

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