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

BYI 2021-02-12

Electro Flo 6 Airway Clearance System

Applicant Med Systems, Inc.

K-Number K201490

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FLL 2021-02-12

Infrared Thermometer

Applicant Shandong Bittel Intelligent Technology Co., Ltd.

K-Number K202368

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FMT 2021-02-12

Panda iRes Warmer, Giraffe Warmer

Applicant GE Healthcare

K-Number K201628

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PHX 2021-02-12

Catalyst OrthoScience R1 Reverse Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K202611

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OLR 2021-02-12

MucoLock Oral Gel

Applicant Pcca, Inc.

K-Number K203091

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EJK 2021-02-12

CleaniCal

Applicant Maruchi

K-Number K201799

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PKR 2021-02-12

gammaCore Sapphire

Applicant Electrocore, Inc.

K-Number K203546

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LRK 2021-02-12

NOA Sleep Apnea and Snoring Device

Applicant Orthoapnea S.L.

K-Number K202651

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FXX 2021-02-12

Surgical Face Mask

Applicant Amphastar Nanjing Pharmaceuticals, Inc.

K-Number K201545

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MUJ 2021-02-12

4D Integrated Treatment Console

Applicant Varian Medical Systems, Inc.

K-Number K203766

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LYZ 2021-02-12

Vinyl Examination Gloves (Yellow)

Applicant Xinying Trading Co., Ltd.

K-Number K203702

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FXX 2021-02-12

Disposable Surgical Mask

Applicant Shanghai Jianzhong Medical Packaging Co., Ltd.

K-Number K202341

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