10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DOME S10
FDA 510(k)
FDA Class 2
·Radiology
Xenon Rebreathing System
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175005088·KIT, XENON CONVENIECE, MOUTHPIECE INCLUDES BACT...
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027506·
FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW
FDA 510(k)
FDA Class 2
·Dental
ENDOTINE FOREHEAD DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 17, 2011
JAGWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EZB·August 22, 2008
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·January 1, 2014
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·September 10, 2014