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

GEH 2024-12-03

Verruca-Freeze H

Applicant Cryosurgery, Inc.

K-Number K243454

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MAI 2024-12-03

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K243467

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MBI 2024-12-03

Fix2Lock (PEEK Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K243470

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CBK 2024-12-02

Ventoux VC2; Ventoux VC3

Applicant Flight Medical Innovations , Ltd.

K-Number K223120

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HRX 2024-12-02

MIDASVu

Applicant Intravu, Inc.

K-Number K243020

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PSY 2024-12-02

Philips IntelliSite Pathology Solution

Applicant Philips Medical Systems Nederland B.V.

K-Number K241871

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KZH 2024-12-02

GripMate

Applicant Synthon Hispania S.L.

K-Number K243232

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JCX 2024-12-02

Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K243418

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FEB 2024-12-02

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

Applicant STERIS Corporation

K-Number K243433

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HSN 2024-12-02

Hintermann Series H2 Total Ankle System

Applicant Vilex, LLC

K-Number K240475

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OAP 2024-12-02

GroWell BT Hair Growth System (GW10042)

Applicant Apira Science, Inc.

K-Number K242619

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POV 2024-11-29

YO Home Sperm Test

Applicant Medical Electronic Systems , Ltd.

K-Number K241628

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