62 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
CoRoent
FDA UDI
Nuvasive, Inc.·00887517573841·CoRoent Ant TLIF Ti, 10x13x40mm 4°
Oticon
FDA UDI
Oticon A/S·05707131167491·ACTO, ITC P PB DIR R BE
OTHER EXTERNAL FIXATION
FDA UDI
Smith & Nephew, Inc.·03596010032119·CENTERING SLEEVE 4MM
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613153045588·SCREWDRIVER BLADE, SLOT-PIN, DENTAL
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857523746·Posterior Blade Size 40 mm
SUPRASPERM SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ASCENDX VCF REDUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 3, 2024
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
SURETEK
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·April 2, 2025
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011
MYNX
FDA Adverse Event
Injury
·ACCESS CLOSURE, INC.·Product code MGB·August 7, 2008
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026