Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LYY 2023-02-22

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

Applicant Shandong Intco Medical Products Co, Ltd.

K-Number K223298

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HAW 2023-02-22

Disposable Pre-calibrated Brain Biopsy Needle 2.0

Applicant PAJUNK GmbH Medizintechnologie

K-Number K230201

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EFB 2023-02-22

TRAUS Air Dental Handpiece

Applicant Saeshin Precision Co., Ltd.

K-Number K221741

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LNH 2023-02-21

NEONA 1.5T MRI System

Applicant Time Medical Limited

K-Number K222259

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QRL 2023-02-21

Verifine® Ease Lancing Device, Verifine® Lancing Device

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K223643

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PZJ 2023-02-21

BOND MMR Antibody Panel

Applicant Leica Biosystems Newcastle, Ltd.

K-Number K213348

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KNW 2023-02-21

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

Applicant Ranfac Corporation

K-Number K223612

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DGC 2023-02-21

Quantia IgE

Applicant Biokit, S.A.

K-Number K214068

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QLG 2023-02-21

FreeStyle Libre 2 System, FreeStyle Libre 3 System

Applicant Abbott Diabetes Care, Inc.

K-Number K223537

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DYB 2023-02-21

Introducer Sheath Kits

Applicant Beijing Demax Medical Technology Co.,Ltd

K-Number K222184

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ONF 2023-02-18

Painless IPL System - KDT750

Applicant Shanghai Omni Laser Skinology Co., Ltd.

K-Number K220214

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GCJ 2023-02-18

FloNavi Endoscopic Fluorescence Imaging System

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K221861

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