10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PELVX INCONTINENCE RING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994309242·BLOCK 7974116 LOADING
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122970·K-WIRE - SINGLE TROCAR 1.1mm DIA x 150mm
IRON 5 X CONC REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
FDA 510(k)
FDA Class 2
·Cardiovascular
ZONA PLUS
FDA Adverse Event
Injury
·ZONA HEALTH·Product code BXB·March 25, 2013
I-STAT ACT KAOLIN CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JBP·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 1, 2014
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