9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FIXAFLOSS
FDA 510(k)
FDA Class 1
·Dental
NA
FDA UDI
KEY SURGICAL, INC.·10849771049859·Steinmann Pins, Double diamond, .1563 inch (4.0...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293685·
HUNTER SCIENTIFIC INJECTION PIPETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BAXTER ACCURA SYSTEM, MODEL 5M5660
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
SAGITTAL SAW ATTACHMENT
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·March 28, 2011
RESOLUTION CLIP DEVICE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code GDO·July 9, 2008
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·June 20, 2018