8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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YSIO
FDA 510(k)
FDA Class 2
·Radiology
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
Ormco
FDA UDI
ORMCO CORPORATION·00889989026771·ARCH P/F EDG.RECT.UP170 X220 PK10
AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
ATRICURE BIPOLAR COAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·Product code OYC·April 29, 2013
MODULAR HEAD COMPONENT 28MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 9, 2011
MINICTH VSYS/PRT/LCK 4NDL LWPF
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code LJT·July 25, 2008