75 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WEGO-PTFE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULCELOOCIN ORAL ULCER PATCH
FDA 510(k)
FDA Unclassified
·Unknown
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
FDA 510(k)
FDA Class 2
·Cardiovascular
COMFORT TOUCH INSUIN PEN NEEDLES
FDA Adverse Event
Malfunction
·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021
MINIMAX STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025
MINIMAX RIGHT ANATOMICAL BROACH SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 14, 2013
30G DENTAL NDL
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DZM·June 22, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·October 14, 2014
MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021
POD PACKING COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·November 8, 2017
POD PACKING COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 23, 2017
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