12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
YEASTEST
FDA 510(k)
FDA Class 1
·Microbiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993554·anteriors; shade BL1; mould UIL
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
FDA 510(k)
FDA Class 2
·Orthopedic
RETROFLEX DILATOR KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·February 26, 2014
EDWARDS ESHEATH INTRODUCER SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021
EDWARDS TF SHEATH UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021
SPRINT FIDELIS
FDA Adverse Event
Death
·MPRI·Product code LWS·March 7, 2013
CLIP, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 16, 2011
KAPPA 700 D
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NVZ·August 8, 2014
MICROFRANCE® INSTRUMENT
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·April 15, 2015
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024