7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MEDULLARY CANAL SCRAPERS
FDA 510(k)
FDA Class 1
·Orthopedic
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Infrared Ear Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 24, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025