158 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NDX DORSAL APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
AGXO
FDA UDI
Oticon A/S·05707131260796·H110, MINIRITE 312 WL SGR AGXO
DreamWear Full
FDA UDI
Respironics, Inc.·00606959046115·DreamWear Full Mask, Small, with Large Frame, w...
COLIBRI DISPOSABLE VITRECTOMY CUTTER
FDA 510(k)
FDA Class 2
·Ophthalmic
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTILENE 3/0 (2) 90CM 2XHR26 CV RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·April 28, 2026
OPTILENE 6/0 (0,7) 75CM 2XDR13 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·March 17, 2026
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·May 29, 2013
*
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code LRP·June 13, 2011
GIA 60-3.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·August 22, 2008
OPTILENE 6/0 (0,7)75CM 2XPRC13B CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·March 25, 2026
OPTILENE 8/0 (0,4) 60CM 2XDR6 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·January 28, 2026
OPTILENE 8/0 (0,4) 60CM 2XDR6 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·January 28, 2026
OPTILENE 8/0 (0,4) 60CM 2XDR6 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·January 28, 2026
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
OPTILENE 6/0 (0,7) 75CM 2XDRC10 CV RCP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·May 9, 2019
OPTILENE 7/0 (0,5) 45CM DSMP11 (M) RCP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·May 13, 2019
OPTILENE 7/0 (0,5) 60CM 2XDR10 CV RCP
FDA Adverse Event
Malfunction
·B/ BRAUN SURGICAL SA·Product code GAW·July 22, 2019
OPTILENE 8/0 (0,4) 60CM 2XDR8F CV RCP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·March 6, 2020
OPTILENE 3/0 (2) 75CM HS21 (M) RCP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019