10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CG+ Arrow JACC
FDA 510(k)
FDA Class 2
·General Hospital
THREADED STEINMANN PINS, DOUBLE END TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016578·
KALIX II IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
KYPHON ANCHOR FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·October 10, 2014
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·June 6, 2013
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 18, 2011
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·December 25, 2019