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

GEI 2023-05-30

Victan

Applicant Jiangsu Haize Medical Scientific Development Co., Ltd.

K-Number K230593

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LLZ 2023-05-30

KBA3D

Applicant S.M.A.I.O

K-Number K223841

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LZA 2023-05-28

Blue Nitrile Examination Gloves Powder Free

Applicant Latrile Gloves Private Limited

K-Number K230601

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OHT 2023-05-26

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

Applicant Shenzhen Ionka Medical Technology Co., Ltd.

K-Number K230739

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DQD 2023-05-26

CORE 500 Digital Stethoscope

Applicant Eko Devices, Inc.

K-Number K230111

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GEX 2023-05-26

Diode Laser System

Applicant Smedtrum Medical Technology Co., Ltd.

K-Number K230580

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OWW 2023-05-26

FlexBand; FlexPatch; FlexBand Plus

Applicant International Life Sciences

K-Number K230316

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HGX 2023-05-26

Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)

Applicant Guangzhou Yongyi Industrial Co., Ltd.

K-Number K223329

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MQL 2023-05-26

V-HYADASE

Applicant Vitromed GmbH

K-Number K222606

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KTL 2023-05-26

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

Applicant Immuno Concepts, N.A. , Ltd.

K-Number K203599

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JWH 2023-05-26

Identity Imprint CR KRS and Identity Imprint PS KRS

Applicant Conformis, Inc.

K-Number K231233

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MUJ 2023-05-26

Eclipse Treatment Planning System (v18.0)

Applicant Varian Medical Systems, Inc.

K-Number K230557

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