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

JEH 2023-05-25

Model 9160 VitaloQUB

Applicant Vitalograph Ireland, Ltd.

K-Number K223818

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PBX 2023-05-25

ThermoTK

Applicant Zimmer Medizinsysteme GmbH

K-Number K213256

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EIH 2023-05-25

Soreal Press, Soreal CAD

Applicant Shenzhen Up3D Technology Co., Ltd.

K-Number K230259

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QBS 2023-05-25

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

Applicant Ge Medical Systems, LLC

K-Number K223491

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FMI 2023-05-25

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle

Applicant Nipro Medical Corporation

K-Number K222852

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NHA 2023-05-25

Dentis s-Clean SQ-SL Narrow Implant System

Applicant Dentis Co., Ltd.

K-Number K230246

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QFJ 2023-05-25

Saranas Early Bird Bleed Monitoring System

Applicant Saranas, Inc.

K-Number K230273

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MLR 2023-05-25

STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K-Number K231169

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FQH 2023-05-25

Armis VeriCyn Wound Wash

Applicant Armis Biopharma, Inc.

K-Number K220759

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LRC 2023-05-25

BB 8 Sinus Dilation Kit

Applicant Excelent, Inc.

K-Number K230258

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LBH 2023-05-25

Dental Desensitizer

Applicant Guangzhou Beogene Biotech Co., Ltd.

K-Number K222891

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DQY 2023-05-25

Stingray LP Catheter

Applicant Boston Scientific

K-Number K231176

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