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

FYC 2022-01-20

Surgical isolation gown

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K-Number K212357

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MWJ 2022-01-19

Biotres

Applicant Biotricity

K-Number K211709

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QIH 2022-01-19

Caption Interpretation Automated Ejection Fraction Software

Applicant Caption Health

K-Number K210747

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OAP 2022-01-19

LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.

Applicant Shenzhen Cosbeauty Technology Co., Ltd.

K-Number K213447

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ELL 2022-01-19

Franz Zirconia Dental Crown

Applicant Franz Biotech, Inc.

K-Number K203072

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QDD 2022-01-19

Jabra Enhance Plus

Applicant GN Hearing A/S

K-Number K213424

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LPH 2022-01-19

R3 Large Head Liners

Applicant Smith & Nephew, Inc.

K-Number K211330

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LZA 2022-01-19

Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)

Applicant Uweport, LLC

K-Number K213227

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LZA 2022-01-19

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove

Applicant Showa Best Glove, Inc.

K-Number K211003

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FXX 2022-01-19

Disposable Medical Mask

Applicant Jiangsu Nanfang Medical Co., Ltd.

K-Number K212826

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HRS 2022-01-19

VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

Applicant Stryker GmbH

K-Number K212581

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MUJ 2022-01-19

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory

Applicant Adaptiiv

K-Number K213438

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