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

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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CGR 2021-04-13

IDS Cortisol

Applicant Immunodiagnostic Systems , Ltd.

K-Number K202136

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HKI 2021-04-13

RetCam Envision

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K203500

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HIR 2021-04-13

Flyte

Applicant Pelvital USA, Inc.

K-Number K210764

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HRS 2021-04-13

Volition Plating System

Applicant Ortho Solutions UK , Ltd.

K-Number K210658

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