29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLASTFREEZE AND BLASTTHAW
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Q-RAD RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GENX CODA AIR PURIFICATION SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SAFIL VIOLET 8/0 (0.4) 30CM 2XDLM6
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·August 9, 2019
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 2, 2013
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·March 25, 2011
ROSE PROCEDURE
FDA Adverse Event
Malfunction
·USGI MEDICAL·Product code KOG·April 1, 2008
SAFIL VIOLET 1 (4) 90CM HR48 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·November 20, 2019
SAFIL UNDYED 4/0 (1,5) 45CM DS19 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·July 5, 2019
SILKAM BLACK 2/0 (3) 10X45CM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·October 7, 2019
SAFIL VIOLET 2/0 (3) 70CM HR40S (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.U.·Product code GAM·September 9, 2021
SAFIL VIOLET 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·August 24, 2021
SAFIL VIOLET 3/0 (2) 70CM HR30 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 24, 2019
SAFIL VIOLET 2/0 (3) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 24, 2019
SAFIL VIOLET 0 (3.5) 5X70CM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·January 29, 2020
SAFIL C VIOLET 2 (5) 15M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 11, 2020
SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·August 6, 2019
SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·September 10, 2019
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
SAFIL VIOLET 3/0 (2) 70CM HR22 (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.U.·Product code GAM·September 15, 2021