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

MOS 2017-12-08

8ch Flex Suite

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K172222

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MHX 2017-12-08

CMS-2000 Central Monitoring System

Applicant Advanced Instumentations, Inc.

K-Number K172966

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QAF 2017-12-08

Cerebrotech CMS-5000

Applicant Cerebrotech Medical Systems

K-Number K171186

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LHQ 2017-12-08

Med-Hot Thermal Imaging Systems

Applicant Med-Hot Thermal Imaging, Inc.

K-Number K171928

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JAK 2017-12-08

Clear Guide SCENERGY

Applicant Clear Guide Medical

K-Number K171677

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EFB 2017-12-08

W&H Assistina Twin

Applicant W&H Dentalwerk Buermoos GmbH

K-Number K171553

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JOH 2017-12-07

Portex Blue Line Ultra Paediatric Tracheosomy Tube

Applicant Smiths Medical Asd, Inc.

K-Number K170720

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JAK 2017-12-07

NeuViz 16 Essence Multi-slice CT Scanner System

Applicant Neusoft Medical Systems Co., Ltd.

K-Number K171198

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LTT 2017-12-07

MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)

Applicant Beckman Coulter, Inc.

K-Number K172912

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LZO 2017-12-07

MasterLoc Stem: Lateralized Plus

Applicant Medacta International S.A.

K-Number K173267

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IYO 2017-12-07

Lilium a-200E

Applicant Lilium Otsuka Co., Ltd.

K-Number K170046

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HSB 2017-12-07

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

Applicant Orthofix Srl

K-Number K173458

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