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

GWO 2018-11-06

Universal Mesh - Sterile

Applicant Stryker Leibinger GmbH & Co KG

K-Number K182425

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QAJ 2018-11-06

Innovo

Applicant Bio-Medical Research, Ltd.

K-Number DEN170049

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GCJ 2018-11-05

1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM

Applicant Stryker

K-Number K182160

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LYR 2018-11-05

PREMIER Platinum HpSA PLUS

Applicant Meridian Bioscience, Inc.

K-Number K182559

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GBM 2018-11-05

Actreen Hi-Lite Cath, Actreen Hi-Lite Set

Applicant B.Braun Medical, Inc.

K-Number K180801

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GCJ 2018-11-05

ConnectedOR Hub with Device and Voice Control

Applicant Stryker

K-Number K181258

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GKZ 2018-11-05

Athelas One

Applicant Athelas, Inc.

K-Number K181288

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JDR 2018-11-05

DynaClipTM Bone Staple

Applicant MedShape, Inc.

K-Number K181781

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DDG 2018-11-05

Tina-quant Transferrin ver.2 (urine application)

Applicant Roche Diagnostics Operations (Rdo)

K-Number K182095

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ORR 2018-11-02

ClearPoint System

Applicant Mri Interventions, Inc.

K-Number K181195

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HSB 2018-11-02

Panta 2 Arthrodesis Nail System

Applicant Integra LifeSciences Corporation

K-Number K181639

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OMP 2018-11-02

Invia White Foam NPWT

Applicant Medela AG

K-Number K180415

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