10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SKYTRON ELITE 7000 MICRO-SURGERY TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NEURODRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Hummingbird Tympanostomy Tube
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GROSH 3FRSL PICC BASIC & 5.5FR MICROINTRO
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code LJS·April 11, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 29, 2012
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 2, 2025
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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