11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FUJI IX
FDA 510(k)
FDA Class 2
·Dental
ITG-MEDEV, INC.
FDA registration
ITG-MEDEV, INC.·1 product·🇺🇸 United States
OPTHALMIC BAR PRISM
FDA 510(k)
FDA Class 1
·Ophthalmic
Ultra Compression Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH A0396
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FGB·December 16, 2016
ENDOPATH DISPOSABLE SURGICAL TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GCJ·February 19, 1998
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·January 6, 2011
5MM MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·July 23, 2014
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017