8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultima HA Coated Half Pins and Wire
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-CLAD ALL POLY CUP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256040·
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·June 11, 2013
PULSE GEN MODEL 105
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 10, 2014
GLUMA DESENSITIZER
FDA Adverse Event
Other
·HERAEUS KULZER, GMBH·Product code KLE·June 2, 2011
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014