16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRUEBLUE
FDA UDI
Respironics, Inc.·00606959028326·L TRUEBLUE WHGR JPN
Sklar®
FDA UDI
SKLAR CORPORATION·10649111184451·BARNES SUCT TUBE ANG 2.0MM 2"
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318
FDA 510(k)
FDA Class 2
·General Hospital
SYNERGY
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·April 22, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 28, 2011
TIBIAL NAIL, STANDARD 10X420MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2008
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 5, 2016
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 3, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·April 16, 2018
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code CBK·March 7, 2013