9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
1.2 MICRON AIR ELIMINATING FILTER
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOFIX MODULSYSTEM
FDA UDI
ORTHOFIX SRL·18053800895771·SELFDRILLING XCALIBER CYLINDRICAL SCREW SS L260...
ORTHOFIX MODULSYSTEM
FDA UDI
ORTHOFIX SRL·18053800895580·SELFDRILLING XCALIBER CYLINDRICAL SCREW SS L260...
PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)
FDA 510(k)
FDA Class 2
·Dental
QUIKREAD CRP CALIBRATOR SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 30, 2010
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·February 4, 2013
ASCENDRA + DELIVERY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·July 17, 2014
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025