103 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
LEONE SPA
FDA UDI
LEONE SPA·08033707001331·THREE DIRECTIONAL SCREW LOWER
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198147·AK3 PS Insert Trial Size 2, 13mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450437230·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm
ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS
FDA 510(k)
FDA Class 1
·General Hospital
HYPERION VISIQUANT ANA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 10, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 5, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 13, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 14, 2026
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·November 16, 2015
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 18, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 19, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 19, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 8, 2025
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·March 30, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·March 31, 2026
UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 5, 2013