7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ASPEN ESMARK BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
FDA 510(k)
FDA Class 2
·Immunology
ACCOLADE II LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 13, 2014
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 13, 2012
BV PULSERA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IZL·September 29, 2010
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017