28 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Becker External Drainage and Monitoring System
FDA 510(k)
FDA Class 2
·Neurology
Drill
FDA UDI
Treace Medical Concepts, Inc.·00810111227179·Drill
ACUMED
FDA UDI
Acumed LLC·10806378014185·3.5mm x 28.0mm Locking Cortical Screw
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742679·Hohmann Retractor 8-3/4" (21.9cm), blade 8mm wide
ACUMED
FDA UDI
Acumed LLC·10806378014192·3.5mm x 28.0mm Locking Cortical Screw
EASI 12 LEAD ALGORITHM
FDA 510(k)
FDA Class 2
·Cardiovascular
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2
FDA 510(k)
FDA Class 2
·General Hospital
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·February 22, 2017
OPHTHALMIC FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 17, 2014
UNKNOWN DEPUY SUMMIT STEM #5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·July 1, 2013
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021
UNK RIGIDFIX CROSSPIN
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·August 25, 2016
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021