28 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HemoCue Hb 801 System
FDA 510(k)
FDA Class 2
·Hematology
ADIN DENTAL IMPLANTS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 12, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 27, 2011
SPECIAL CONNECTED TWICE AS TOUGH CUFFS, ANKLE
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code FMQ·June 6, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 18, 2008
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·March 17, 2022
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 17, 2020
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·September 29, 2021
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·June 3, 2022
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 15, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·January 30, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·February 6, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·July 27, 2021
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024