9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEUROMARK System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEALIX ADVANCE PEEK ANCHOR w/DYNACORD
FDA UDI
Medos International Sàrl·10886705029495·HEALIX ADVANCE PEEK ANCHOR w/DYNACORD PEEK Anch...
ACETAL
FDA 510(k)
FDA Class 1
·Dental
Idys LLIF 3DTi
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 6, 2008
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·August 24, 2011
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 5, 2013
HFN 125 DEG 9MM X 180MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·October 25, 2022
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·August 31, 2022