10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bashir S-B Endovascular Catheter, Ref. No. 7101
FDA 510(k)
FDA Class 2
·Cardiovascular
HI-DOW-XP
FDA 510(k)
FDA Class 2
·Neurology
ZOLL E SERIES WITH SPCO/SPMET OPTION
FDA 510(k)
FDA Class 3
·Cardiovascular
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
PALINDROME SAPPHIRE 23/40KT VT
FDA Adverse Event
Malfunction
·COVIDIEN MANUFACTURING·Product code MSD·October 22, 2014
4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAILS-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·June 27, 2013
6.5MM TI CANCELLOUS BONE SCREW FULLY THREADED/30M
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·July 1, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018