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 2022-11-01

POSE™ Health Care Surgical Mask

Applicant America'S Supply Chains

K-Number K223270

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JOJ 2022-11-01

3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

Applicant 3M Company

K-Number K222508

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MEG 2022-11-01

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle

Applicant Jiangsu Kangbao Medical Equipment Co., Ltd.

K-Number K221247

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IZL 2022-11-01

Combined High Frequency X-ray Source

Applicant Suzhou Powersite Electric Co., Ltd.

K-Number K222258

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HBC 2022-10-31

ORiGO System

Applicant Bien-Air Surgery SA

K-Number K213697

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PGY 2022-10-31

CW60N

Applicant Wide Corporation

K-Number K222722

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KNT 2022-10-31

Standard Tapered Bougie, 38 Fr.

Applicant Standard Bariatrics, Inc.

K-Number K222085

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FKX 2022-10-31

Fresenius Liberty Select Cycler

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K222318

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FMI 2022-10-31

IO Needle Safety Sheath

Applicant Actuated Medical, Inc.

K-Number K220890

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MQK 2022-10-31

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

Applicant Bonraybio Co., Ltd.

K-Number K221810

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PGY 2022-10-31

CL24N

Applicant Wide Corporation

K-Number K222717

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NFJ 2022-10-31

Excelsior

Applicant Merit Cro, Inc.

K-Number K220929

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