15 results
·
37ms
·
Sources: EU EUDAMED, US FDA
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
FDA 510(k)
FDA Class 2
·Hematology
ADS-GEL AND INSULATING-GEL
FDA 510(k)
FDA Class 2
·Dental
BROAD SELF-COMPRESSING PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 10, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024