17 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MACCONKEY AGAR
FDA 510(k)
FDA Class 1
·Microbiology
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581161100001·A-FIT® 1. MOLAR UPR RGT SZ 11
CARDIOCAM MODEL 9CSY0799
FDA 510(k)
FDA Class 2
·Radiology
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZENIX
FDA UDI
Zoll Medical Corporation·00198843000094·ZENIX, EMS FIRE CONFIGURATION
ZENIX
FDA UDI
Zoll Medical Corporation·00198843003163·ZENIX, EMS, PROFESSIONAL CONFIGURATION
ZENIX
FDA UDI
Zoll Medical Corporation·00198843000131·ZENIX, EMS BLS + VENTILATION CONFIGURATION
ZENIX
FDA UDI
Zoll Medical Corporation·00198843003255·ZENIX, EMS FIRE CONFIGURATION + TEMP
ZENIX
FDA UDI
Zoll Medical Corporation·00198843000056·ZENIX, EMS STANDARD CONFIGURATION
ZENIX
FDA UDI
Zoll Medical Corporation·00198843000117·ZENIX, EMS BLS CONFIGURATION
ZENIX
FDA UDI
Zoll Medical Corporation·00198843000070·ZENIX, EMS CRITICAL CARE CONFIGURATION
ZENIX
FDA UDI
Zoll Medical Corporation·00812394022946·ZENIX, EMS, TOTAL CARE
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
CALF IMPLANT
FDA Adverse Event
Other
·HANSON MEDICAL·Product code MIB·August 12, 2010
CORAIL2 STD SIZE 12
FDA Adverse Event
Injury
·DEPUY FRANCE SAS-3003895575·Product code KWA·May 6, 2015
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021