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

QEH 2022-05-19

Artiglass NRFitTM Tip L.O.R. Glass Syringes

Applicant Artiglass Srl

K-Number K213800

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LGD 2022-05-19

ARCHITECT Toxo IgG

Applicant Abbott Laboratories

K-Number K210596

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FXX 2022-05-19

Medical Surgical Mask (Planar type)

Applicant Hunan Chopard Medical Devices Co., Ltd.

K-Number K220824

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PIF 2022-05-19

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection

Applicant Cardinalhealth

K-Number K213174

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MUH 2022-05-19

PAPAYA & PAPAYA Plus

Applicant Genoray Co., Ltd.

K-Number K220423

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FXX 2022-05-19

Procedure Mask with Ear Loops and Surgical Mask with Ties

Applicant Safesource Direct, LLC

K-Number K221134

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CAZ 2022-05-19

BD Epilor Syringe

Applicant Becton, Dickinson and Company

K-Number K210983

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FMK 2022-05-19

Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K220370

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MBF 2022-05-19

SMR Reverse Liner

Applicant Lima Corporate S.P.A.

K-Number K220792

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MBI 2022-05-19

X-Twist PEEK Suture Anchor

Applicant Parcus Medical, LLC

K-Number K221135

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QJF 2022-05-18

MolecuLight I:X

Applicant MolecuLight, Inc.

K-Number K213840

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LPH 2022-05-18

BENCOX Mirabo Cup System

Applicant Corentec Co., Ltd.

K-Number K220468

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