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

ELC 2018-03-08

AW-100

Applicant Micron Corporation

K-Number K171150

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EBF 2018-03-08

NMF004A

Applicant GC America, Inc.

K-Number K173500

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NSI 2018-03-08

PillCam Patency System

Applicant Given Imaging , Ltd.

K-Number K180171

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QEW 2018-03-08

Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister

Applicant Penumbra, Inc.

K-Number K180105

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FDI 2018-03-07

Rotatable Snares, Non-Rotatable Snares

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K172758

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GAW 2018-03-07

Aesculap Optilene Nonabsorbable Suture

Applicant Aesculap, Inc.

K-Number K180321

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PEK 2018-03-07

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

Applicant Globus Medical, Inc.

K-Number K180156

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EHD 2018-03-07

PORT-X IV

Applicant Genoray Co., Ltd.

K-Number K172810

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GEX 2018-03-07

Dornier Medilas H Solvo 35 Laser

Applicant Dornier Medtech America

K-Number K180350

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NBW 2018-03-07

On Call Express Mobile Blood Glucose Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K180196

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GEX 2018-03-07

LMT-3000

Applicant Lameditech Co. , Ltd.

K-Number K172818

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GCJ 2018-03-07

ALVUE Balloon Dilation System

Applicant Globus Medical, Inc.

K-Number K171939

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