8 results · 17ms · Sources: EU EUDAMED, US FDA

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SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ACCULIF TL-PEEK CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

ONLINE DAT II COCAINE II

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CORONARY SDS

FDA Adverse Event
Death ·CORDIS CORPORATION·Product code MAF·December 13, 2010

TENDRIL ST

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

QUANTUM MAVERICK MONORAIL PTCA CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORP.·Product code LOX·April 6, 2006

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012