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

OHT 2022-03-28

Hand-held IPL device(JOVS Graphene Hair Removal Device)

Applicant Shenzhen Qianyu Technology Co., Ltd.

K-Number K214113

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MSC 2022-03-28

SancDam Latex Oral Dam

Applicant Sanctuary Health Sdn. Bhd.

K-Number K212037

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CAH 2022-03-27

GGM Breathing Circuit Bacterial Filter

Applicant Great Group Medical Co, Ltd.

K-Number K210352

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LZA 2022-03-26

Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)

Applicant Ksg Medicare Sdn. Bhd.

K-Number K220215

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LZA 2022-03-26

Clover Glove

Applicant Clover Glove Company Limited

K-Number K213729

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LZA 2022-03-26

Powder Free Nitrile Examination Gloves, Orange

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K220229

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DQA 2022-03-25

Biobeat Platform, BB-613WP Patch

Applicant Biobeat Technologies , Ltd.

K-Number K212153

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FXX 2022-03-25

3 Ply Medical Grade Single Use Procedural Disposable Face Mask

Applicant Kdi Med Supply

K-Number K220637

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MAX 2022-03-25

Toro-L Interbody Fusion System

Applicant Integrity Implants, Inc.

K-Number K213355

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BZD 2022-03-25

Luna G3 BPAP System

Applicant 3B Medical, Inc.

K-Number K212263

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QEW 2022-03-25

Artix Thrombectomy Device

Applicant Inari Medical

K-Number K220600

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FXX 2022-03-25

Medical Surgical Mask (Model: JM92, JM92B)

Applicant Guangdong Jia Mei Biological Technology Co.Ltd

K-Number K220187

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