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

QOI 2023-05-19

SafeBreak® Vascular

Applicant Lineus Medical

K-Number K223486

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LZO 2023-05-19

Exactech® Alteon® Short Tapered Wedge

Applicant Exactech, Inc.

K-Number K221323

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QNP 2023-05-19

GI Genius System 100 and GI Genius System 200

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number K231143

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ODP 2023-05-19

Ventana C Spinal System

Applicant Spinal Elements, Inc.

K-Number K222833

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MXD 2023-05-19

BIOMONITOR IV

Applicant Biotronik, Inc.

K-Number K230375

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QJI 2023-05-19

iLet® Dosing Decision Software

Applicant Beta Bionics, Inc.

K-Number K220916

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KRO 2023-05-19

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®

Applicant Stryker

K-Number K230416

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DKZ 2023-05-19

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

Applicant Xenta Biomedical Science Co., Ltd.

K-Number K231137

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KGI 2023-05-19

VirtuOst

Applicant O.N. Diagnostics

K-Number K220402

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KFM 2023-05-19

Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

Applicant Qura S.R.L

K-Number K220842

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FXX 2023-05-19

Disposable Medical Mask

Applicant Guangzhou Fuzelong Hygiene Material Co., Ltd.

K-Number K222545

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DHA 2023-05-19

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

Applicant Abbott Laboratories

K-Number K230790

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