11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMI Remote EEG Monitoring System
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114117·SIMCOE CORTEX EXTR 23GA 0.4MM TXT PK/10
TAPERLOC COMPLETE RASP/PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304632523·
entré Model PD08-U
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES 3.5MM CORTEX SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
CLINITEK STATUS+
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FNL·November 10, 2008
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 12, 2011
ARTICUL/EZE BALL 28 +5 BR
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH·Product code JDI·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025