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

FGE 2023-09-06

Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K230127

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LNH 2023-09-06

MAGNETOM Viato.Mobile

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232482

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HKI 2023-09-06

Phoenix ICON, Phoenix ICON GO

Applicant Neolight, LLC

K-Number K223575

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LPL 2023-09-06

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

Applicant Art Optical Contact Lens, Inc.

K-Number K230824

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HWC 2023-09-05

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

Applicant Innovate Orthopaedics Limited

K-Number K231819

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BTT 2023-09-05

F&P 820 Humidification System

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K223684

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QEW 2023-09-05

ICHOR 14F Embolectomy System

Applicant Ichor

K-Number K230743

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CEW 2023-09-05

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K221197

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OYX 2023-09-05

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

Applicant Suzhou Sniper Medical Technologies Co., Ltd.

K-Number K221869

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EBI 2023-09-05

Polibond

Applicant Zirkonzahn Srl

K-Number K232691

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IOR 2023-09-05

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL

Applicant Ki Mobility, LLC

K-Number K200583

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LNH 2023-09-05

Promaxo MRI System II

Applicant Promaxo, Inc.

K-Number K232361

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