20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Lite
FDA 510(k)
FDA Class 2
·Physical Medicine
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AFINION ACR AND ACR CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
PEN NDL 32G 4MM PRO 100 BOX 1200 CA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 22, 2024
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026
CASBLOOD SECONDARY SETS
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·June 5, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·July 22, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·October 15, 2014
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025
OPTIPAC 80 BIOMET BC R
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026
BIOMET BONE CEMENT R 40 -3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·April 8, 2025
OPTIPAC 80 BIOMET BC R
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·February 21, 2025