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

PQJ 2017-04-24

Oculeve Intranasal Tear Neurostimulator Device

Applicant Oculeve, Inc.

K-Number DEN160030

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HRS 2017-04-24

EVOS Small Fragment Plating System

Applicant Smith & Nephew, Inc.

K-Number K170887

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IZL 2017-04-24

FDR AQRO (DR-XD 1000)

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K170858

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HRS 2017-04-24

ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension

Applicant Wrightmedicaltechnologyinc

K-Number K163650

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DSA 2017-04-24

ECG Disposable Lead Wire

Applicant APK Technology Co., Ltd.

K-Number K170536

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MNR 2017-04-24

Apnea Risk Evaluation System (ARES), Model 620

Applicant Watermark Medical

K-Number K160499

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HKX 2017-04-24

VX130 Ophthalmic Diagnostic Device

Applicant Luneau Sas

K-Number K162067

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LXJ 2017-04-24

MindMotionPRO

Applicant Mindmaze SA

K-Number K162748

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GEI 2017-04-21

joimax Endovapor 2

Applicant Joimax GmbH

K-Number K170358

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DZE 2017-04-21

TSIII BA Fixture

Applicant Osstem Implant Co., Ltd.

K-Number K163088

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DXN 2017-04-21

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor

Applicant Caretaker Medical, LLC

K-Number K163255

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CJE 2017-04-21

Randox RX Daytona Plus Alkaline Phosphatase (ALP)

Applicant Randox Laboratories Limited

K-Number K162275

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