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

DQY 2017-06-07

Venture 038 catheter

Applicant Vascular Solutions, Inc.

K-Number K171335

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DTQ 2017-06-07

Advanced Perfusion System 1

Applicant Terumo Cardiovascular Systems Corporation

K-Number K163531

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ELW 2017-06-07

HySil Impression Materials

Applicant Osstem Implant Co., Ltd.

K-Number K170736

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FAD 2017-06-07

Kwart Retro-Inject Ureteral Stent

Applicant Cook Incorporated

K-Number K162109

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JWY 2017-06-07

Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K170772

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LXB 2017-06-07

Cochlear Baha SoundArc

Applicant Cochlear Americas

K-Number K171088

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IZL 2017-06-07

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris

Applicant Minxray, Inc.

K-Number K171353

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LNH 2017-06-07

Vantage Titan 1.5T, MRT-1510, M-Power GX

Applicant Toshibamedical Systems Corporation

K-Number K170412

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MHX 2017-06-06

EK12 Algorithm

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K170155

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IYN 2017-06-06

SonoBook Series Diagnostic Ultrasound System

Applicant Chison Medical Imaging Co., Ltd.

K-Number K170374

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PNL 2017-06-06

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K171429

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MML 2017-06-06

Altomed Malhotra Platinum Segments

Applicant Altomed Limited

K-Number K170591

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