71 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHYSIOLOGICAL PRESSURE MEASUREMENT SYS
FDA 510(k)
FDA Class 2
·Cardiovascular
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435062537·MCD Screw 3.0 x 38 mm M2
non lo...
GLOBAL UNITE FX RSA EPI CENTER
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code PHX·November 5, 2025
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 5, 2014
PENUMBRA SYSTEM CANISTER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code BTA·March 15, 2010
ENDURANT ILIAC STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·November 13, 2012
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 46MM FOR IM NAILS
FDA Adverse Event
Malfunction
·SYNTHES MEZZOVICO·Product code HWC·October 11, 2017
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS
FDA Adverse Event
Malfunction
·SYNTHES MEZZOVICO·Product code HWC·October 11, 2017
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·August 7, 2017
GLOBAL UNITE STD STEM SZ 10
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code HSD·November 5, 2025
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025