12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
FDA 510(k)
FDA Class 2
·Radiology
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
FDA 510(k)
FDA Class 1
·General Hospital
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 3, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 3, 2024
TBD
FDA Adverse Event
Malfunction
·Product code KOD·April 5, 2018
PROVISIONAL LINER LOCKING SCREW
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·July 23, 2011
PALL FREEZING BAG WITH 25 ML SEPARABLE
FDA Adverse Event
Malfunction
·ENSATEC, S.A. DE C.V.·Product code KSR·October 10, 2008
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013