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

FER 2023-12-22

WellCare Anoscope

Applicant Well Care (Wuhan) Medical Technology Co., Ltd.

K-Number K230439

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ITX 2023-12-22

TP Pivot Pro Needle Guide

Applicant Civco Medical Solutions

K-Number K233109

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LNH 2023-12-22

MAGNETOM Sola; MAGNETOM Altea

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232535

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PSY 2023-12-22

NanoZoomer S360MD Slide scanner system

Applicant Hamamatsu Photonics K.K.

K-Number K233027

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QCI 2023-12-22

CloudTMS Edge for OCD

Applicant Teleemg, LLC

K-Number K233742

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NBW 2023-12-22

VivaChek Link Plus Blood Glucose Monitoring System

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K233058

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EBF 2023-12-22

TopCEM Dual Cure Resin Cement

Applicant Rizhao Huge Biomaterials Company, Ltd.

K-Number K233082

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FLL 2023-12-22

Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383

Applicant Alicn Medical Shenzhen, Inc.

K-Number K232338

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LQY 2023-12-22

Apex Locator (AL-Pex), Apex Locator (AL-Pex+)

Applicant Changzhou Haili Medical Co., Ltd.

K-Number K232717

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KCT 2023-12-22

Anthogyr INTEGRAL Guided Surgery Cassettes

Applicant Anthogyr

K-Number K233264

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MYN 2023-12-22

qXR-LN

Applicant Qure.Ai Technologies

K-Number K231805

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QEP 2023-12-22

NeuMoDx CT/NG Assay 2.0

Applicant Neumodx Molecular, Inc.

K-Number K230267

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