15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
FDA 510(k)
FDA Class 2
·Microbiology
Chisel
FDA UDI
ELLIQUENCE, LLC·00846338006402·
MONOSYN VIOLET 1 (4) 8X45CM HRB37STO(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·July 7, 2016
Gibralt
FDA UDI
Choice Spine, LP·00840996169431·GIBRALT,DRILL,FIXED,2.4X24
PREVISION HIP SYSTEM WITH RECON RING
FDA 510(k)
FDA Class 2
·Orthopedic
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
FDA 510(k)
FDA Class 2
·Radiology
GMK HINGE FEMUR SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNAIONAL SA·Product code KRO·August 21, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 14, 2013
3 MOTOR ADVANCED BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 28, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 11, 2020
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025