19 results
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19ms
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Sources: EU EUDAMED, US FDA
NEEDLE, ACUPUNCTURE
FDA 510(k)
FDA Class 2
·General Hospital
RICH-MAR MODEL V ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
TUBULICID RED LABEL
FDA 510(k)
FDA Class 2
·Dental
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024212220·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024212213·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024635289·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024635302·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024212206·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024635272·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024212237·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024635296·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024635326·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024212183·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024212190·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024635319·
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NTE·February 15, 2013
CSS CANNULATED SCREW SYSTEM
FDA Adverse Event
Injury
·ORTHOHELIX SURGICAL DESIGN·Product code HWC·January 11, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014
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