51 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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ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
FDA 510(k)
FDA Class 2
·Neurology
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
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
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 16, 2025
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2019
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 8, 2013
OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2014
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
CD HORIZON SOLERA SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·August 22, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·October 17, 2017