17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CastleLoc-P Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814176·GENUMEDI PT SILVER R I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII
MSC LIPID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
R2-MRI ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019
INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MAF·October 6, 2014
ZOLL STAT PADZ
FDA Adverse Event
ZOLL MEDICAL CORP.·Product code DRX·March 12, 2013
CAPTURE-CMV INDICATOR RED CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code LJO·June 28, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020
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