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

QVP 2023-05-05

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number DEN210038

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OCC 2023-05-05

Panther Fusion AdV/hMPV/RV Assay

Applicant Hologic, Inc.

K-Number K231017

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FLE 2023-05-05

Lexa MINI (RIS-303, RIS-305)

Applicant W&H Sterilization S.R.L.

K-Number K223858

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QOI 2023-05-04

Orchid Safety Release Valve

Applicant Linear Health Sciences, LLC

K-Number K230266

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NJM 2023-05-04

Ceramic Brackets Orthometric

Applicant Orthometric - Industria E Comercio DE Produtos Medicos

K-Number K222847

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MMW 2023-05-04

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

Applicant Nucleix , Ltd.

K-Number K203245

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IYN 2023-05-04

Lumify Diagnostic Ultrasound System

Applicant Philips Ultrasound

K-Number K223771

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QKB 2023-05-04

Auto Segmentation

Applicant Ge Medical Systems, LLC

K-Number K230082

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FMF 2023-05-04

Sol-Guard Auto-disable Syringe

Applicant Sol-Millennium Medical, Inc.

K-Number K220713

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PAY 2023-05-04

Pollogen STOP U Model UXV Device

Applicant Pollogen, Ltd.

K-Number K220322

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OWI 2023-05-04

OLYMPIC Deformity Band System

Applicant Astura Medical

K-Number K222097

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MMI 2023-05-04

Alinity i STAT High Sensitivity Troponin-I

Applicant Abbott Laboratories Diagnostics Division

K-Number K230994

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