20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
GBI TSH NEONATAL SCREENING KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code NVY·January 13, 2014
ITREL 3
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·June 17, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 17, 2011
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·February 4, 2016
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
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 1, 2015
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