48 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MICROKERATOME, MODEL MK-2000
FDA 510(k)
FDA Class 1
·Ophthalmic
Biograph Vision
FDA 510(k)
FDA Class 2
·Radiology
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CARE FUSION
FDA Adverse Event
Injury
·CARE FUSION·Product code CBK·December 17, 2012
SUPRAMID BLACK 5/0 (1) 45CM DS16
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·January 17, 2019
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 6, 2013
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 8, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
SUPRAMID WHITE 2/0 (3) 100M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·November 4, 2019
SUPRAMID BLACK 4/0 (1.5) 45CM HS15
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·July 31, 2019
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
DAFILON BLUE 2/0 (3) 75CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·July 1, 2019
DAFILON BLUE 4/0 (1.5) 45CM DS16 (M)
FDA Adverse Event
Injury
·B.BRAUN SURGICAL SA·Product code GAR·October 15, 2019
DAFILON BLUE 2/0 (3) 75CM DS30
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·October 4, 2019
SUPRAMID BLACK 2/0 (3) 5X45CM
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAR·August 20, 2020
SUPRAMID BLACK 4/0 (1.5) 45CM DS16
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·May 15, 2019
FLEXOCRIN 6/0 (0.7) 60CM DS9
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·June 5, 2019
DAFILON BLUE 4/0 (1.5) 75CM DS19
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·May 28, 2019
DAFILON BLUE 5/0 (1) 45CM DS16
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·February 7, 2020
DAFILON BLUE 3/0 (2) 75CM DGMP24 DDP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·July 1, 2019