28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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All-Bond Universal w/BAC (not finalized)
FDA 510(k)
FDA Class 2
·Dental
AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
FDA 510(k)
FDA Class 2
·Orthopedic
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
FDA 510(k)
FDA Class 2
·Radiology
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
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
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 29, 2019
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 27, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL·Product code KRD·October 1, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL, INC.·Product code KRD·June 19, 2025
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK UROLOGICAL INC·Product code FAD·May 13, 2016
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 8, 2016