10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135073·
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
FDA 510(k)
FDA Class 2
·General Hospital
HORIZON 1000 CARDIAC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 15, 2021
OLYMPUS SURGMASTER ELECTROSURGICAL UNIT
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·May 26, 2014
INSYNC III MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 5, 2010
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 3, 2012
COMPRESS SEGMENTAL ANCHOR PLUG 14MM W/DRILL SET AND W/PIN INSERTER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 16, 2016
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022