12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEEDLE, SPRAY
FDA 510(k)
FDA Class 2
·Orthopedic
BD Prevue II Peripheral Vascular Access System
FDA UDI
Bard Access Systems, Inc.·00801741215001·BD Prevue II Probe Holder
CoRoent
FDA UDI
Nuvasive, Inc.·00887517809377·Interlock II, 7x17x14mm 10°
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515200265·Kolbel Self-Retaining Retr blades, 36x36mm, pair
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471188613·.022 U/L Std Comb. Weld Size#10
Performa®
FDA UDI
Merit Medical Systems, Inc.·00884450004197·
True Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 18, 2014
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSA MFG·Product code FKX·October 1, 2012
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·July 27, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014