10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PEEPERS TANNING GOGGLES
FDA 510(k)
FDA Class 1
·Ophthalmic
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909140952·REVELATION DIAMOND 909-040SC-S - 5 PACK
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
FDA 510(k)
FDA Class 2
·Microbiology
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 14, 2013
GENERAL SURGERY
FDA Adverse Event
Other
·MEDLINE INDUSTRIES, INC.·Product code GDY·December 2, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015