84 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFINITY OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221046291·Unitek(TM) Molar Band General Purpose Wide Hard...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180529690·Extended Arsenal Tap 7.5mm
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code LXH·February 10, 2020
PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSTART MRX, MODELS M3535A OR M3536A
FDA 510(k)
FDA Class 3
·Cardiovascular
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 12, 2018
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 13, 2019
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 13, 2019
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2019
M2A-MAGNUM MOD HD SZ 54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2013
ARTICULEZE M HEAD 36MM +12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 8, 2011
CAREASSIST
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·September 10, 2008
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 18, 2019
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·March 25, 2019
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·May 9, 2018
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·May 9, 2018
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·November 6, 2018