8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MICRO-INGRESSOR HANDIPIECE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T
FDA 510(k)
FDA Class 2
·Physical Medicine
PREMIER ASP/CD RECHARGEABLE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MECTALIF ANTERIOR
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·October 30, 2025
VANGUARD ANT STABILIZED BEARING 14X63
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 11, 2013
HIRES 90K ADVANTAGE IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·July 18, 2014
PROMOTE ACCEL CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020