Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

GEI 2018-09-04

EUSRA RF Electrode

Applicant Starmed Co., Ltd.

K-Number K181249

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GEX 2018-09-04

ECHOLASER X4

Applicant El.En Electronic Engineering Spa

K-Number K181510

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LZO 2018-09-04

Exactech Alteon Monobloc Revision Stem

Applicant Exactech, Inc.

K-Number K181532

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NQL 2018-09-04

NeoBase 2 Non-derivatized MSMS Kit

Applicant Wallac Oy, Subsidiary of Perkinelmer, Inc.

K-Number K173568

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MHX 2018-09-04

Surveyor Patient Monitor

Applicant Mortara Instrument, Inc.

K-Number K173765

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EIH 2018-09-02

Upcera Glaze Paste, Glaze Powder, and Glaze Liquid

Applicant Liaoning Upcera Co., Ltd.

K-Number K181167

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GWQ 2018-09-01

Cadwell Zenith System

Applicant Cadwell Industries, Inc.

K-Number K181466

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LYR 2018-08-31

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

Applicant DiaSorin, Inc.

K-Number K181464

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NBW 2018-08-31

CareSens S Fit Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K180866

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QAD 2018-08-31

IlluminOss Bone Stabilization System

Applicant Illuminoss Medical, Inc.

K-Number K181228

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LLZ 2018-08-31

AmCAD-UT Detection 2.2

Applicant Amcad Biomed Corporation

K-Number K180006

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CAF 2018-08-31

Intelligent Mesh Nebulizer

Applicant Qingdao Future Medical Technology Co., Ltd.

K-Number K171549

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