23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECSYS FSH CALSET II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134090·Trial, TLIF, 27L OB STR 7Deg, 9mm
GentleYAG 12/15/18 Delivery System W/DCD
FDA UDI
Candela Corporation·00817495022321·Delivery System Assembly
4003409
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·October 31, 2023
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522124846·4 ELECTRODE EVO RECORDER PACKED, DUTCH
MODIFICATION TO T-REX BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Cardiovascular
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 15, 2024
INSET I
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 19, 2025
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
6.0MM TI MATRIX SCREW
FDA Adverse Event
Malfunction
·SYNTHES (USA) BRANDYWINE·Product code NKB·February 28, 2013
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·March 1, 2011
ROTALINK CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MCX·February 21, 2008
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 15, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
PRECISION SPECTRA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 8, 2015