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

NQX 2024-10-25

Xpert® SA Nasal Complete

Applicant Cepheid®

K-Number K243070

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LPL 2024-10-25

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism

Applicant Bruno Vision Care, LLC

K-Number K240918

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LOX 2024-10-25

Pantera Pro; Pantera LEO

Applicant Biotronik, Inc.

K-Number K242969

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OYK 2024-10-25

Salto Talaris Ankle PSI System

Applicant 3D Systems, Inc.

K-Number K243173

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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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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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