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

QOF 2024-10-25

QIAstat-Dx Respiratory Panel Mini

Applicant QIAGEN GmbH

K-Number K242353

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QNS 2024-10-25

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle

Applicant Ocuject, LLC

K-Number K242956

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QIH 2024-10-25

TumorSight Viz

Applicant SimBioSys, Inc.

K-Number K243189

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KNT 2024-10-25

CORGRIP* SR NG/NI Tube Retention System

Applicant Avanos Medical, Inc.

K-Number K241185

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SDD 2024-10-25

Dexter L6 System

Applicant Distalmotion SA

K-Number DEN230084

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PGY 2024-10-25

LCD Monitors C310S, G310S, C316S, G316S, C616W

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K243031

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DQA 2024-10-25

Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)

Applicant Shenzhen Yimi Life Technology Co., Ltd.

K-Number K240092

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GEH 2024-10-25

Freeze Point & Private Label Versions

Applicant Cryoconcepts LP

K-Number K242625

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QIH 2024-10-25

Neurophet AQUA (V3.1)

Applicant Neurophet., Inc.

K-Number K242215

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JWH 2024-10-25

BKS Revision System

Applicant Ortho Development Corp.

K-Number K242984

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OYK 2024-10-25

Cadence Ankle PSI System

Applicant 3D Systems, Inc.

K-Number K243174

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IYN 2024-10-24

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

Applicant Telefield Medical Imaging (Shenzhen) Limited

K-Number K241554

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