12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINK(TM) External Fixator
FDA 510(k)
FDA Class 2
·Orthopedic
Sonic
FDA UDI
Sbo Hearing A/S·05714464052424·RADIANT 80 FW 1.3.0
Trial BiPolar Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215045548·
MOVES SLC
FDA 510(k)
FDA Class 2
·Anesthesiology
THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
I-STAT EG7+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·BARD SHANNON LTD·Product code FTL·July 18, 2013
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
ENDURANT II ILIAC STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 12, 2024