10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Optima XR240amx
FDA 510(k)
FDA Class 2
·Radiology
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108185·DREWS NEEDLE HOLDER STRAIGHT WITH LOCK
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
FDA 510(k)
FDA Class 2
·Orthopedic
BRAINLAB KNEE
FDA 510(k)
FDA Class 2
·Neurology
V.A.C.ULTA THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 23, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
ATTAIN PERFORMA
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·October 10, 2014
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 15, 2011
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019