25 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERIOPATCH
FDA 510(k)
FDA Unclassified
·Unknown
NexxZr™ / W-98-30-UT-A400-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271138729·
AGXO
FDA UDI
Oticon A/S·05707131163776·K130, MINIRITE CBE AGXO
Sklar®
FDA UDI
SKLAR CORPORATION·10649111189715·CLEAR PLASTIC TRAY MD 4" DEEP
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971185·
AUTOSTAT II ENA-6 PROFILE ELISA
FDA 510(k)
FDA Class 2
·Immunology
KONICA DIRECT DIGITIZER REGIUS MODEL 350
FDA 510(k)
FDA Class 2
·Radiology
9611993-2025-103054
FDA Adverse Event
Injury
·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·July 11, 2025
V200 / ESPRIT
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 16, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 28, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNT·May 19, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·May 20, 2021
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 7, 2021
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code CBK·December 9, 2020
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 21, 2021
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 9, 2013
CHOICE GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·September 19, 2014
M2A MAGNUM PF CUP 52MM X 46MM ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 25, 2011
Infant Warmer System (IWS)
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·January 18, 2017
Infant Warmer System (IWS)
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017