363 results
·
21ms
·
Sources: EU EUDAMED, US FDA
NOVASYS TRANSURETHRAL RF SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STb Copper Ni-Ti
FDA UDI
ORMCO CORPORATION·00889989024999·STb STRAIGHTWIRE CUNITI 14 DIA MED PK10
K042172
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
FDA 510(k)
FDA Class 2
·Radiology
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
HG II FIXTURE SYSTEM
FDA Adverse Event
Injury
·HIOSSEN INC.·Product code DZE·April 4, 2013
PRODISC-L IMPLANT SUPERIOR ENDPLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MJO·March 30, 2011
CONTAK RENEWAL 4
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·September 2, 2015
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026