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

IYE 2018-03-13

ThinkQA

Applicant Dosisoft

K-Number K180106

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IYN 2018-03-13

Voluson S8/ Voluson S10/ Voluson S10 Expert

Applicant GE Healthcare

K-Number K180374

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MOB 2018-03-13

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

Applicant Phadia AB

K-Number K173792

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OQI 2018-03-12

Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners

Applicant Exactech, Inc.

K-Number K173583

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LLZ 2018-03-12

SICAT Endo

Applicant Sicat GmbH & Co. KG

K-Number K180262

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LCX 2018-03-12

Preview Digital Pregnancy Test

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K173229

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GAM 2018-03-12

REXMONO, PDREX

Applicant Sm Eng Co., Ltd.

K-Number K173779

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KNW 2018-03-12

Corvocet Biopsy System

Applicant Merit Medical Systems, Inc.

K-Number K180450

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FAD 2018-03-12

RocaJJ Soft Stents

Applicant Promepla Sam

K-Number K173734

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PGW 2018-03-10

Acclarent ENT Navigation System

Applicant Acclarent, Inc.

K-Number K173628

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OLV 2018-03-09

Grass TWin

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K173690

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FAD 2018-03-09

VORTEK URETERAL DOUBLE LOOP STENT

Applicant Coloplast Corp.

K-Number K180057

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