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

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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CGZ 2018-10-30

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K182072

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JOY 2018-10-30

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

Applicant Sysmex America, Inc.

K-Number K182062

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DRE 2018-10-29

MC3 Vascular Access Kit 21030

Applicant Mc3 Incorporated

K-Number K182914

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GKZ 2018-10-29

HemoScreen Hematology Analyzer

Applicant Pixcell Medical Technologies, Ltd.

K-Number K180020

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