13 results
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30ms
·
Sources: EU EUDAMED, US FDA
Disposable Medical Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Esprit™
FDA UDI
ABBOTT VASCULAR INC.·08717648353789·Esprit™ BTK Everolimus Eluting Resorbable Scaff...
Esprit™
FDA UDI
ABBOTT VASCULAR INC.·08717648353765·Esprit™ BTK Everolimus Eluting Resorbable Scaff...
Esprit™
FDA UDI
ABBOTT VASCULAR INC.·08717648353741·Esprit™ BTK Everolimus Eluting Resorbable Scaff...
Powder Free Blue Nitrile Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
ZOLL Propaq M
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 9, 2013
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 19, 2018
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 10, 2014
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023