17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed Stryker External Fixation Devices
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar
FDA UDI
SKLAR CORPORATION·10649111451836·SKLHN METZ SCISS CVD SERR 12 INCHES
Ellis External Mini Fixator
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575229413·fixation pins with thread,thread length 17 mm
LESIONPOINT RF CANNULA
FDA 510(k)
FDA Class 2
·Neurology
TANDA MAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 16, 2025
STEM: AMISTEM H HA COATED STD STEM SIZE 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 2, 2019
ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM
FDA Adverse Event
Injury
·LDR MEDICAL·Product code OVD·November 13, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 8, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011
AMISTEM H, HA COATED STEM 0 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 2, 2016
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 17, 2019
ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·April 23, 2019
ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·January 27, 2023
ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·May 13, 2023
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023