158 results · 23ms · Sources: EU EUDAMED, 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