16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4CIS Marlin PEEK ACIF Cage
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Bernafon AG·05711584087183·ZR1, KIT 312 2.4G NFM 90 R BE ZERENA 1
ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
FDA 510(k)
FDA Class 2
·Physical Medicine
ELECSYS DIGOXIN CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 19, 2022
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 12, 2017
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 27, 2016
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 15, 2023
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·June 28, 2023
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·March 5, 2021
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