7 results
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20ms
·
Sources: EU EUDAMED, US FDA
KCK INDUSTRIES' SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XEBRA DICOM IMAGE BROWSER
FDA 510(k)
FDA Class 2
·Radiology
NuVasive® Precept Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
LINOX SMART S 60
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·June 13, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 16, 2010
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 6, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015