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

GWQ 2020-03-17

NeuralScan System

Applicant Medeia, Inc.

K-Number K192753

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HSX 2020-03-17

Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill

Applicant Zimmer, Inc.

K-Number K200151

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IYO 2020-03-17

Shear Wave Quantificational Ultrasound Diagnostic System

Applicant Wuxi Hisky Medical Technologies Co., Ltd.

K-Number K200136

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MXC 2020-03-17

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

Applicant Abbott (St. Jude Medical)

K-Number K193310

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KCT 2020-03-17

SterilContainer S2 System

Applicant Aesculap, Inc.

K-Number K193582

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NDC 2020-03-17

EndoTool IV 1.10

Applicant Monarch Medical Technologies, LLC

K-Number K200443

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PGY 2020-03-16

OptikView GUP2103CMI

Applicant The Linden Group Corp

K-Number K191705

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GEX 2020-03-16

Epic 980

Applicant Biolase, Inc.

K-Number K193486

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NFJ 2020-03-16

CONTINUUM PACS

Applicant Integrated Ophthalmic Systems, Inc.

K-Number K200385

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GEX 2020-03-16

SANDRO Dual

Applicant Wontech Co., Ltd.

K-Number K200110

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LLZ 2020-03-16

AnatomicAligner

Applicant The Methodist Hospital Research Institute D/B/A Houston

K-Number K190767

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DXC 2020-03-16

Sunmed Disposable Angio-Closure Pads

Applicant Sunny Medical Device (Shenzhen) Co., Ltd.

K-Number K191827

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