8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MRX-750
FDA 510(k)
FDA Class 1
·Radiology
Nu-Edge II Metal Bracket
FDA UDI
TP ORTHODONTICS INC·00192029047569·UL LAT
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
FDA 510(k)
FDA Class 2
·Orthopedic
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·December 14, 2010
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILLIPS MEDICAL SYSTEMS·Product code MKJ·January 4, 2013
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·July 14, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021