13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Amendia Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741524550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674152455060·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111310300·SISTRUNK DISS SCISS CVD 5 3/4"
Low Profile Acetabular Reamer 55
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057589·
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
IMPRESSIX
FDA 510(k)
FDA Class 2
·Dental
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·BAYER MEDICAL CARE, INC.·Product code MWI·October 6, 2014
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 7, 2013
INTEGRITY RX CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MAF·June 21, 2011
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019