12 results
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26ms
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Sources: EU EUDAMED, US FDA
SIMPLATE
FDA 510(k)
FDA Class 2
·Hematology
JOBST Opaque
FDA UDI
BSN MEDICAL, INC.·00035664029111·OPAQUE 15-20 MM HG WAIST HIGH CLOSED TOE SMALL ...
Ceramill
FDA UDI
Amann Girrbach AG·E4947612501·
Daytona
FDA UDI
Seaspine Orthopedics Corporation·10889981131579·Precontoured Rod, 4.5 x 250mm
Centronail Titanium Supracondylar Nailing System
FDA UDI
ORTHOFIX SRL·18032937162178·CENTRONAIL TITANIUM SUPRACONDYLAR NAIL D.11 MM-...
MULTICATH EXPERT
FDA 510(k)
FDA Class 2
·General Hospital
OC-FLEX Flexible IntraOral Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 2, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 26, 2012
LEAD MODEL 302-20
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 15, 2010
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025