11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROVIL NOVO
FDA 510(k)
FDA Class 2
·Dental
STERIZONE VP4 Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
IVENT 2001 MRI CONDITIONAL
FDA 510(k)
FDA Class 2
·Anesthesiology
SOMATOM DEFINITION FLASH
FDA Adverse Event
Malfunction
·SIEMENS AG·Product code JAK·February 22, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014
TITAN TOUCH SCRO ZERO ANG 18CM
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·May 25, 2018
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·September 24, 2014
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 26, 2015
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 5, 2015
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026