27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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R&D RET-LINE KIT
FDA 510(k)
FDA Class 2
·Hematology
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540466·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540442·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540435·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540428·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540473·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540459·
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
FDA 510(k)
FDA Unclassified
·Unknown
ULTRACISION SURG, DEV, BLADES 5MM OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 16, 2006
ST. JOSEPH HSP BALTIMORE MD1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
POPULAR PLASTICS·Product code IKX·March 20, 2013
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·March 14, 2008
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
SMART, PERFUSION PACKS, CONNECTORS, TUBING
FDA Adverse Event
Malfunction
·LIVANOVA USA·Product code DWE·August 1, 2023
UNK_ULTRACISION HARMONIC FOCUS
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 1, 2025
CSC14 CARDIOLOGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·March 10, 2016