10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
DARCO HEADLESS COMPRESSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
re.t.a Reuseable Tampon Applicator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·August 18, 2021
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 18, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
TI LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code MNI·December 20, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024