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

MAI 2022-03-28

OSSIOfiber Suture Anchor

Applicant OSSIO , Ltd.

K-Number K213415

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EIH 2022-03-28

CERABIEN MiLai

Applicant Kuraray Noritake Dental, Inc.

K-Number K213147

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DZE 2022-03-28

T3 Pro Implants

Applicant Biomet 3i, LLC

K-Number K213672

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JAK 2022-03-28

Syngo.CT Dual Energy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K212889

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LZA 2022-03-28

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)

Applicant Taishan Weibang Medical Equipment Co., Ltd.

K-Number K213662

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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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