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

FMI 2016-03-17

Sungshim Insulin Pen Needle

Applicant Sung Shim Medicare Co., Ltd.

K-Number K152334

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NQE 2016-03-17

Specular Microscope CEM- 530

Applicant Nidek Co., Ltd.

K-Number K151706

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LZA 2016-03-17

Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color

Applicant Minghao Medical Products Co., Ltd.

K-Number K152707

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LRK 2016-03-17

OVENT

Applicant Oventus Manufacturing Pty, Ltd.

K-Number K160234

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JDO 2016-03-17

CONQUEST FN

Applicant Smith & Nephew

K-Number K152686

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GWG 2016-03-17

Apollo System

Applicant Penumbra, Inc.

K-Number K152699

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OTJ 2016-03-17

Endo Keeper

Applicant Nelis

K-Number K152598

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KNS 2016-03-17

Rezum System

Applicant Nxthera, Inc.

K-Number K160417

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PLO 2016-03-17

FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

Applicant Biofire Diagnostics, LLC

K-Number K160462

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MWI 2016-03-17

Axeo 3 Patient Monitor

Applicant Axeo Medical Technologies, LLC

K-Number K153079

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LZA 2016-03-17

Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color

Applicant Jiayuan Medical Products Co., Ltd.

K-Number K152705

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FMZ 2016-03-17

Giraffe OmniBed Carestation CS1

Applicant Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company

K-Number K152814

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