8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SIEMENS FLUID DELIVERY SYSTEM, MMT-9500
FDA 510(k)
FDA Class 2
·General Hospital
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 4, 2022
CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
FDA 510(k)
FDA Class 2
·General Hospital
EPIQ Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
LCS COMP RP INSERT LG 12.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·December 17, 2010
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 15, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 21, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021