11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: United States
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RELOAD FOR 60MM ECHELON
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021
FIBULA COMP LOCK PLATE 10H STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 24, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
CORONOID PLATE RT STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·June 9, 2016
SONICFILL COMPOSITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·June 26, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SCL)·Product code JAA·July 27, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 24, 2008
S3 SHOULDER PLATE 4 HOLE RIGHT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013
POLIGRIP/SUPER POLIGRIP
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·August 4, 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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018