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

QJG 2022-09-26

OtoSight Middle Ear Scope

Applicant Photonicare, Inc.

K-Number K222655

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FXX 2022-09-26

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

Applicant Jingzhou Haixin Green Cross Medical Products Co., Ltd.

K-Number K222266

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QRL 2022-09-26

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device

Applicant Bionime Corporation

K-Number K221062

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MCW 2022-09-26

Auryon Atherectomy Catheters

Applicant Eximo Medical, Ltd.

K-Number K220116

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EOQ 2022-09-26

Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V

Applicant Olympus Medical Systems Corp.

K-Number K221631

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FAJ 2022-09-26

Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)

Applicant Zhuhai Pusen Medical Technology Co., Ltd.

K-Number K222602

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GEX 2022-09-25

Resonic Rapid Acoustic Pulse Device

Applicant Zeltiq Aesthetics, Inc.

K-Number K222629

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LYY 2022-09-24

Single-use medical latex examination gloves (LG100)

Applicant Fitone Latex Products Co., Ltd. Guangdong

K-Number K222693

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LZA 2022-09-24

Powder Free Nitrile Examination Glove

Applicant Dainam Glove Joint Stock Company

K-Number K212751

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LZA 2022-09-24

Betel Gloves Nitrile Examination Glove Powder Free

Applicant Betel Care Sdn. Bhd.

K-Number K222342

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LZA 2022-09-24

Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid

Applicant Onetexx Sdn Bhd

K-Number K222294

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KGO 2022-09-24

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K221718

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