24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STA-QUALITY HBPM/LMWH KIT
FDA 510(k)
FDA Class 2
·Hematology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890103240·Zirlux UCLA Plastic Abut Eng
Oxygen Sensor
FDA UDI
MERCURY ENTERPRISES, INC.·10641043103241·
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450021712·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0100240·Caddie, Fixed Cross Links, 5.5mm Assembly
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100240·SNII Tap, 4.50mm
Matira
FDA UDI
Kalitec Direct LLC·B07307K0100240·Assembly, Caddie, Screws, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100240·Caddie, Fixed Cross Links, 5.5mm, Assesmbly
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 17, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 17, 2025
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
FDA 510(k)
FDA Class 2
·Neurology
O2/CO2 NASAL FILTERLINE
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2025
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
JUVEDERM ULTRA XC TSK US
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·March 14, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 11, 2011