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

EGS 2023-05-24

General Cutting Straight

Applicant Nakanishi, Inc.

K-Number K230106

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FRO 2023-05-24

coactiv+™ Antimicrobial Wound Gel

Applicant Kane Biotech, Inc.

K-Number K223259

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NHA 2023-05-24

SIMDA Abutment

Applicant Simda Co., Ltd.

K-Number K223663

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IMJ 2023-05-24

Reprieve by RegenesisTM

Applicant Regenesis Biomedical, Inc.

K-Number K223620

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LLZ 2023-05-24

Avatar Medical Software V1

Applicant Avatar Medical

K-Number K222035

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LNH 2023-05-23

uMR Omega

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K230152

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LLZ 2023-05-23

ADAS 3D

Applicant Adas3D Medical S.L.

K-Number K230803

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MEH 2023-05-23

ACTERA™ hip system

Applicant Conformis, Inc.

K-Number K231178

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QDQ 2023-05-23

Genius AI Detection 2.0 with CC-MLO Correlation

Applicant Hologic, Inc.

K-Number K230096

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LLZ 2023-05-23

ROSA Hip System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K231162

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OAP 2023-05-23

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

Applicant Hubei Yjt Technology Co.,Ltd

K-Number K230134

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LZA 2023-05-23

Green Non Sterile Powder Free Nitrile Examination Gloves

Applicant Central Medicare Sdn Bhd

K-Number K230564

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