8 results
·
35ms
·
Sources: EU EUDAMED, US FDA
TMX-C1/C2 TRADMILL CONTROLLER ACCESS.
FDA 510(k)
FDA Class 1
·Physical Medicine
The BAG manual resuscitator and accessories
FDA 510(k)
FDA Class 2
·Anesthesiology
EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
FDA 510(k)
FDA Class 2
·Physical Medicine
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 6, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 29, 2012
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·September 28, 2010
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026