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

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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LZA 2022-09-24

Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K221887

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JOJ 2022-09-23

3M Attest Hydrogen Peroxide Indicator Tape 1228

Applicant 3M Company

K-Number K222152

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JAK 2022-09-23

XACT Robotic System, ACE Model

Applicant Xact Robotics, Ltd.

K-Number K213759

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FPA 2022-09-23

NeutrArt

Applicant Asset Medikal Tasarim As.

K-Number K221481

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EIH 2022-09-23

Esthetic Colorant

Applicant Kuraray Noritake Dental, Inc.

K-Number K220369

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GYB 2022-09-23

Conductive Gel

Applicant Tone-A-Matic International, Inc.

K-Number K221724

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