21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292817·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012559·K-Wires, Single trocar, .045-inch (1.1mm) diame...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049132·K-Wires, Single trocar, .045-inch (1.1mm) diame...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021528·
GOLDFINGER DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 27, 2019
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 22, 2013
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code DTK·April 27, 2011
GE OEC 6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 5, 2016
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 3, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·April 16, 2018
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026