10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131264770·RIA, KIT 312 WL DIR R H BE
R3 XLPE LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2024
R3 XLPE INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 1, 2014
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·May 24, 2013
PRIME 5TH WHEEL STRETCHER, 30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 12, 2011
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023