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

FXX 2021-06-02

Disposable Medical mask

Applicant Hubei Wanli Protective Products Co., Ltd.

K-Number K210150

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FXX 2021-06-02

ASM-301 Level 3 Surgical Mask

Applicant American Surgical Mask Company, LLC

K-Number K211440

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NXC 2021-06-02

6MS Invisible Aligner

Applicant Sms Opco, LLC

K-Number K210652

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FXX 2021-06-02

Disposable Surgical Face Mask

Applicant Jiangxi Heying Pharmaceutical Co., Ltd.

K-Number K210429

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QDQ 2021-06-02

Transpara 1.7.0

Applicant Screenpoint Medical B.V.

K-Number K210404

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FXX 2021-06-02

Surgical Face Mask

Applicant Rfx+Care Manufactoring Co., Ltd.

K-Number K203190

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FOZ 2021-06-02

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

Applicant Becton, Dickinson and Company

K-Number K200891

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MRD 2021-06-02

NATRELLE INSPIRA Single Use Sizers for Gel Implants

Applicant Allergan

K-Number K203229

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QMY 2021-06-02

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)

Applicant Mahana Therapeutics, Inc.

K-Number K211372

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HRS 2021-06-02

DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)

Applicant DePuy Synthes

K-Number K211051

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QPF 2021-06-02

Cognoa ASD Diagnosis Aid

Applicant Cognoa, Inc.

K-Number DEN200069

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MAX 2021-06-02

SeaSpine WaveForm A Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K210583

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