72 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
FDA 510(k)
FDA Class 1
·Microbiology
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254657·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970560·
DMS 300-2, 300-3 AND 300-4
FDA 510(k)
FDA Class 2
·Cardiovascular
PROLYTE ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973479·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970881·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973080·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973707·
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014
LOCKING TITANIUM ADAPTER
FDA Adverse Event
Malfunction
·KANAE CO.,LTD.·Product code KDJ·June 11, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 15, 2011
UNITIP CATHETER FOR HR GI
FDA Adverse Event
Injury
·UNISENSOR AG·Product code FFX·August 25, 2014
GRYPHON P BR DS ANCHOR W/ORTHOCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·September 19, 2022
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