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

OAP 2022-05-12

Laser hair growth helmet

Applicant Kam Yuen Plastic Products , Ltd.

K-Number K213025

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LZA 2022-05-11

Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

Applicant Grand Work Plastic Products Co., Ltd.

K-Number K220250

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IYN 2022-05-11

Versana Balance

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K220446

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PEM 2022-05-11

Disposable Barrier Sleeves

Applicant Premium Plus (Dongguan) Limited

K-Number K220662

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FXX 2022-05-11

Procedure Mask, Surgical Mask

Applicant A Plus International, Inc.

K-Number K213001

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OLT 2022-05-11

Wireless EEG System

Applicant Pascall Systems, Inc.

K-Number K213299

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IYE 2022-05-11

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips

Applicant Macromedics BV

K-Number K212909

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FYA 2022-05-11

Plus Medical Cover Gown

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K-Number K213177

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FDT 2022-05-11

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

Applicant Olympus Medical Systems Corp.

K-Number K220587

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HIS 2022-05-11

Durex Condom with Benzocaine

Applicant Rb Health (Us), LLC

K-Number K211152

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PGY 2022-05-10

RadiForce MX243W

Applicant Eizo Corporation

K-Number K221136

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NVK 2022-05-10

Dental diode laser

Applicant Shenzhen Soga Technology Co., Ltd.

K-Number K214008

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