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

IYN 2018-10-31

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

Applicant Canon Medical Systems Corporation

K-Number K182679

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GEX 2018-10-31

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro

Applicant Fotona D.O.O.

K-Number K182088

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LQR 2018-10-30

Wilson-Cook Mini Basket

Applicant Wilson-Cook Medical, Inc.

K-Number K182381

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DYW 2018-10-30

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

Applicant Tomy, Inc.

K-Number K180718

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JFY 2018-10-30

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K182063

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FZP 2018-10-30

LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier

Applicant Ethicon Endo-Surgery, LLC

K-Number K181488

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KOB 2018-10-30

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

Applicant Cook Incorporated

K-Number K182066

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FDF 2018-10-30

DiLumen Endolumenal Interventional Platform

Applicant Lumendi, LLC

K-Number K182540

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GEH 2018-10-30

Frozen C

Applicant B.M. Tech. Worldwide Co., Ltd.

K-Number K182392

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HRS 2018-10-30

AOS Calcaneal Plating System

Applicant Advanced Orthopaedic Solutions

K-Number K182466

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KOD 2018-10-30

UroGen Ureteral Catheter

Applicant Urogen Pharma, Ltd.

K-Number K180354

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OWB 2018-10-30

Cios Spin

Applicant Siemens Medical Solutions USA, Inc.

K-Number K181550

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