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

LZA 2016-09-01

EMG Pink Nitrile Examination Glove Powder Free

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K161320

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EOQ 2016-09-01

Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor

Applicant Ambu A/S

K-Number K161656

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LEJ 2016-09-01

IBL 5000 Tanning Booth

Applicant Ibl Acquisitions, LLC

K-Number K152405

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ETY 2016-09-01

Madsen Zodiac

Applicant Gn Otometrics

K-Number K161707

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GKZ 2016-09-01

BC-5390 Auto Hematology Analyzer

Applicant Mindray Bio-Medical Electronics Co., Ltd.

K-Number K160429

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HGX 2016-09-01

Hi bebe plus

Applicant Bistos Co., Ltd.

K-Number K160274

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LNH 2016-09-01

SIGNA Voyager

Applicant GE Healthcare

K-Number K161567

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KTI 2016-09-01

Elation Pulmonary Balloon Dilation

Applicant Merit Medical Systems, Inc.

K-Number K161392

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EHD 2016-09-01

EzRay Air (Model VEX-P300)

Applicant VATECH Co., Ltd.

K-Number K161063

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KIF 2016-09-01

MTA2.2 MATERIAL

Applicant Avalon Biomed, Inc.

K-Number K161239

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EIH 2016-09-01

XP202

Applicant 3M Deutschland GmbH

K-Number K161922

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OMP 2016-08-31

RENASYS-G Gauze Dressing Kits with Soft Port

Applicant Smith & Nephew, Inc.

K-Number K162129

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