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

OLO 2016-05-16

Aesculap OrthoPilot Next Generation

Applicant Aesculap Implant Systems, LLC

K-Number K153396

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GWF 2016-05-16

MagPro R20

Applicant Tonica Elektronik A/S

K-Number K160280

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ONX 2016-05-16

Lumipulse G ROMA

Applicant Fujirebio Diagnostics,Inc.

K-Number K160090

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NEU 2016-05-13

UltraCor Twirl Breast Tissue Marker

Applicant Bard Peripheral Vascular, Inc.

K-Number K152510

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MUA 2016-05-13

Bindex BI-100

Applicant Bone Index Finland , Ltd.

K-Number K152020

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HEX 2016-05-13

LT-300 HD

Applicant Lutech Industries, Inc.

K-Number K160380

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IYE 2016-05-13

ArcCHECK-MR

Applicant Sun Nuclear Corporation

K-Number K160057

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EBG 2016-05-13

DD medical polymers

Applicant Dental Direkt GmbH

K-Number K153490

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PGY 2016-05-13

Diagnostic Imaging Color LCD Monitor

Applicant Nec Display Solutions , Ltd.

K-Number K161057

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LLZ 2016-05-13

EzDent-i / E2 / Prora View

Applicant Ewoosoft Co., Ltd.

K-Number K161117

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IYN 2016-05-13

SonoSite iViz Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K161119

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NQQ 2016-05-13

Perimeter Otis 1.0 Optical Coherence Tomography System

Applicant Perimeter Medical Imaging, Inc.

K-Number K160240

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