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

GEX 2025-02-14

Pastelle Pro

Applicant Wontech Co., Ltd.

K-Number K241527

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POK 2025-02-14

Brainomix 360 e-ASPECTS

Applicant Brainomix Limited

K-Number K243294

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GEX 2025-02-14

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

Applicant Wontech Co., Ltd.

K-Number K241643

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MWI 2025-02-14

WARD-CSS (v1.2.x)

Applicant Ward 24/7 Aps

K-Number K241958

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QAS 2025-02-14

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K250248

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MMX 2025-02-14

LimFlow V-Ceiver

Applicant LimFlow, Inc.

K-Number K242776

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NHA 2025-02-14

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K243212

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QIH 2025-02-14

AVIEW CAC

Applicant Coreline Soft Co., Ltd.

K-Number K243696

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PBF 2025-02-13

Newclip Patient-matched instrumentation non sterile PSI

Applicant Newclip Technics

K-Number K243912

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LCX 2025-02-13

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

Applicant Assure Tech., LLC

K-Number K250117

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NRY 2025-02-13

Penumbra System (Reperfusion Catheter RED 72)

Applicant Penumbra, Inc.

K-Number K242104

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GEI 2025-02-13

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

Applicant Boston Aesthetics, Inc.

K-Number K241832

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