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

PNZ 2017-04-05

XprESS ENT Dilation System

Applicant Entellus Medical, Inc.

K-Number K163509

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MUH 2017-04-04

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight

Applicant VATECH Co., Ltd.

K-Number K170731

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NKB 2017-04-04

CD HORIZON Fenestrated Screw Set

Applicant Medtronic Sofamor Danek USA

K-Number K170347

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MHX 2017-04-04

Nihon Kohden Vital Sign Telemeter

Applicant Nihon Kohden Corporation

K-Number K163459

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MAX 2017-04-04

Zavation IBF

Applicant Zavation, LLC

K-Number K162206

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MPB 2017-04-04

Zenysis Short-Term Dialysis Catheter

Applicant C.R. Bard, Inc.

K-Number K163458

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KMW 2017-04-04

OsteoMed PINNACLE Driver

Applicant Osteomed

K-Number K162544

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MQL 2017-04-04

SAGE Vitrification Kit and SAGE Vitrification Warming Kit

Applicant CooperSurgical, Inc.

K-Number K170560

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OAP 2017-04-04

iHelmet Hair Growth System

Applicant Slinph Technologies Co., Ltd.

K-Number K162782

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OLO 2017-04-04

Mazor X

Applicant Mazor Robotics , Ltd.

K-Number K163221

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JJX 2017-04-04

Beta-CrossLaps CalCheck 5

Applicant Roche Diagnostics

K-Number K170678

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MJN 2017-04-04

ER-REBOA Catheter

Applicant Prytime Medical Devices, Inc.

K-Number K170411

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