12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EcoVue Sterile and Non-Sterile Ultrasound Gels
FDA 510(k)
FDA Class 2
·Radiology
Asymmetric Keel Punch Guide Size 9
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215121792·
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
MONOPOLAR CAUTERY
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF INC.·Product code GEI·June 3, 2013
EON MINI 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 23, 2008
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023
ATLAS GOLD
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023
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