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

HRS 2022-05-27

CoLink PCR Plating System

Applicant In2bones USA, LLC

K-Number K213698

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NAY 2022-05-27

Senhance Surgical System

Applicant Asensus Surgical, Inc.

K-Number K220889

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OAP 2022-05-26

Laser Hair Growth Comb

Applicant Kam Yuen Plastic Products , Ltd.

K-Number K213027

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OVB 2022-05-26

Barrigel Injectable Gel

Applicant Palette Life Sciences

K-Number K220641

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ERL 2022-05-26

AMADEO, M-UK1015 (incl. attachments and accessories)

Applicant W&H Dentalwerk Buermoss GmbH

K-Number K213221

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HIH 2022-05-26

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

Applicant Meditrina, Inc.

K-Number K213171

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NUC 2022-05-26

Astroglide Ultra Gentle Gel

Applicant Biofilm, Inc.

K-Number K220355

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OUR 2022-05-26

iFuse Bedrock Granite Implant System

Applicant SI-BONE, Inc.

K-Number K220195

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QLG 2022-05-26

FreeStyle Libre 3 Continuous Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K213996

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LZC 2022-05-26

Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

Applicant Hl Rubber Industries Sdn Bhd

K-Number K220545

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QLG 2022-05-26

FreeStyle Libre 3 Continuous Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K212132

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LZA 2022-05-26

Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)

Applicant Grand Work Plastic Products Co., Ltd.

K-Number K220249

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