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

FXX 2021-04-15

GD Disposable Medical Face Mask

Applicant Jiangsu Guangda Medical Material Group Co., Ltd.

K-Number K201718

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QFM 2021-04-14

BriefCase, RIB Fractures Triage (RibFx)

Applicant Aidoc Medical , Ltd.

K-Number K202992

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HWC 2021-04-14

Cannulated Fasteners and Nuts

Applicant OsteoCentric Technologies

K-Number K210754

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FRO 2021-04-14

AMSure® Single Use Saline Topical Solution

Applicant Amsino Medical, Inc.

K-Number K201138

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KIF 2021-04-14

Metapex Plus

Applicant Meta Biomed Co., Ltd.

K-Number K202617

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LOX 2021-04-14

Artimes pro Balloon Dilatation Catheter

Applicant Brosmed Medical Co., Ltd.

K-Number K203390

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CBK 2021-04-14

F&P Visairo NIV Mask Range

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K203449

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NEU 2021-04-14

HydroMARK Breast Biopsy Site Marker

Applicant Devicor Medical Products, Inc.

K-Number K210752

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PGY 2021-04-14

CX30N (CX30PQX)

Applicant Wide Corporation

K-Number K210493

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FXX 2021-04-14

DEFEND Ear-loop Face Masks

Applicant Young Dental Manufacturing Co. 1, LLC

K-Number K201127

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GCJ 2021-04-13

1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes

Applicant Stryker

K-Number K210088

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HKI 2021-04-13

NFC-600 Automated Portable Retinal Camera

Applicant Crystalvue Medical Corporation

K-Number K210197

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