10 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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AViTA Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code FMI·January 24, 2024
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MYOVISION 3.0 WIREFREE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 17, 2011
DELTA CER HEAD 12/14 36MM +5
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LZO·July 12, 2013
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 31, 2024
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 23, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018