13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONDUIT Lateral Switch Plate
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517629777·CoRoent Ant TLIF Ti, 12x11x32mm 15°
N/A
FDA UDI
PENTAX OF AMERICA, INC.·04961333242634·VGA TO S-VIDEO CABLE
TEMA ELBOW
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JDC·July 26, 2024
ALARIS SMARTSITE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026
Optomed Smartscope M5 with Optomed Smartscope FA
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CMD 22-1325 HUMERAL IMPLANT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JDB·December 10, 2023
CMD 22-1325 ULNAR STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code JDB·October 21, 2023
ENSEAL G2 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 3, 2014
INTELLIVUE INFORMATION CENTER CLIENT
FDA Adverse Event
Death
·PHILIPS HEALTHCARE - ANDOVER·Product code MHX·August 19, 2011
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·July 1, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024