4 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code IBJ·May 28, 2013
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Recall
Terminated
·Derma Pen, LLC·Product code PIU·February 5, 2015
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Enforcement
Class II
·Terminated·Derma Pen, LLC·September 16, 2015
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
FDA Recall
Terminated
·SynCardia Systems Inc.·Product code LOZ·October 21, 2016