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

OAP 2024-11-01

Breo Laser Hair Growth Comb (Scalp 3L)

Applicant Shenzhen Breo Technology Co., Ltd.

K-Number K242620

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GAG 2024-11-01

Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)

Applicant Covidien (Part of Medtronic)

K-Number K240881

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JWJ 2024-11-01

Total Wrist Arthroplasty System (TWA)

Applicant Skeletal Dynamics, Inc.

K-Number K243381

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GEX 2024-11-01

ORTIV (ORTIV-BL, ORTIV-WH)

Applicant Mvitro Co., Ltd.

K-Number K241646

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JKA 2024-11-01

BD Vacutainer® One Use Holder

Applicant Becton, Dickinson and Company

K-Number K242320

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FED 2024-11-01

Over-tube (TR-1108A)

Applicant Fujifilm Corporation

K-Number K243091

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KTT 2024-11-01

Monkey Bars Pin to Bar External Fixation System

Applicant Paragon 28, Inc.

K-Number K242452

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OIY 2024-11-01

DePuy ATTUNE Total Knee System

Applicant Depuy Orthopedics, Inc.

K-Number K242665

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GIM 2024-10-31

BD Vacutainer® Citrate Blood Collection Tubes

Applicant Becton, Dickinson and Company

K-Number K240455

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QYX 2024-10-31

SmartCardia 7L Platform (MCT)

Applicant Smartcardia SA

K-Number K240653

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CAD 2024-10-31

V80 Anesthetic Vaporizer (V80)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K240375

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FRO 2024-10-31

Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo

Applicant Bionova Medical, Inc.

K-Number K243181

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