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

QIH 2025-05-07

BrightHeart View Classifier

Applicant Brightheart

K-Number K243684

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JCX 2025-05-07

Cary

Applicant Excitus AS

K-Number K251111

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INI 2025-05-07

Mobility Scooter (Model X-01, X-02)

Applicant Wuyi Aichi Industry & Trade Co., Ltd.

K-Number K242975

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PHR 2025-05-07

SDF Pro

Applicant Belport Company, Inc., Gingi-Pak

K-Number K250222

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PZO 2025-05-06

ANKYRAS

Applicant Mentice Spain S.L.

K-Number K250160

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GEX 2025-05-06

Alma Veil

Applicant Wontech Co., Ltd.

K-Number K251094

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FGB 2025-05-06

Single-use Flexible Ureteroscope

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K250785

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OHT 2025-05-06

IPL Hair Removal Device (KCA511/KCA516/KCA522)

Applicant Dongguan Boyuan Intelligent Technology Co.,Ltd

K-Number K250253

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OHT 2025-05-06

IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)

Applicant Foshan Newface Electronic Technology Co., Ltd.

K-Number K243017

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IZL 2025-05-06

!M1

Applicant Solutions For Tomorrow AB

K-Number K241980

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MLW 2025-05-05

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

Applicant Thermasolutions, LLC

K-Number K240447

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FYA 2025-05-05

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

Applicant Dae Myung Chemical Co., Ltd. (Vietnam)

K-Number K242937

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