10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GDLS-200
FDA 510(k)
FDA Class 2
·Dental
BIOLOX DELTA
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBL·May 28, 2025
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PALM PUMP
FDA 510(k)
FDA Class 2
·General Hospital
STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA Adverse Event
Other
·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·April 24, 2013
PARADIGM QUICKSERTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code KZH·September 11, 2014
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·May 10, 2011
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