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

IWB 2016-04-20

Leksell Gamma Knife Icon

Applicant Elekta Instrument AB

K-Number K160440

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HKY 2016-04-19

Icare ic100

Applicant Icare Finland OY

K-Number K153694

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HWC 2016-04-19

Bicortical Fixation Screw & Washer Nut System

Applicant First Ray, LLC

K-Number K153638

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ODB 2016-04-19

LumenR Tissue Retractor System

Applicant Lumenr, LLC

K-Number K153698

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GEI 2016-04-19

VASOVIEW HemoPro Endoscopic Vessel Harvesting System

Applicant Maquet Cardiovascular, LLC

K-Number K153194

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FRO 2016-04-19

Microcyn Plus Skin and Wound Hydrogel

Applicant Oculus Innovative Sciences

K-Number K153648

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JAK 2016-04-19

AIRO Computed Tomography (CT) X-ray System

Applicant Mobius Imaging

K-Number K160126

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HSD 2016-04-19

Arthrex Univers Revers CA Heads and Adapters

Applicant Arthrex, Inc.

K-Number K151527

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IYN 2016-04-19

Fujifilm Sonosite Vevo MD Imaging System

Applicant FUJIFILM Sonosite, Inc.

K-Number K160674

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DJG 2016-04-18

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests

Applicant Chemtron Biotech, Inc.

K-Number K153192

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DQA 2016-04-18

Pulse Oximeter (MD300M/MD300K2)

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K152563

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HGX 2016-04-15

Spectra S1Plus and Spectra S2 Plus

Applicant Uzinmedicare Co.

K-Number K150476

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