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

EBF 2018-08-22

GrandioSO x-tra

Applicant Voco GmbH

K-Number K181312

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DXQ 2018-08-21

Reusable NIBP Cuff

Applicant Orantech, Inc.

K-Number K173197

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DSY 2018-08-21

exGraft, exGraft Carbon ePTFE Vascular Grafts

Applicant Peca Labs

K-Number K180957

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ODG 2018-08-21

PENTAX Medical Endoscopic Ultrasound System

Applicant Pentax of America, Inc.

K-Number K182004

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OMP 2018-08-21

PICO 7 Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K180698

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FLL 2018-08-21

Fever Scout

Applicant VivaLNK, Inc.

K-Number K181013

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LYR 2018-08-21

H. PYLORI QUIK CHEK

Applicant Techlab, Inc.

K-Number K181379

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DTE 2018-08-21

Medtronic Model 5392 External Pulse Generator (EPG)

Applicant Medtronic, Inc.

K-Number K181973

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NBW 2018-08-21

Confidence Blood Glucose Monitoring System

Applicant Applied Biomedical, LLC

K-Number K173658

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GCJ 2018-08-21

SIMPLYSTRONG, SIMPLYEZEE

Applicant Genicon, Inc.

K-Number K181791

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LYR 2018-08-21

H. PYLORI CHEK™

Applicant Techlab, Inc.

K-Number K181400

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ODP 2018-08-21

ATEC Cervical Spacer System

Applicant Alphatec Spine, Inc.

K-Number K181435

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