8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tyto Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
CETRA
FDA UDI
Orthofix US LLC·18257200120437·2-LEVEL PLATE ASSEMBLY, 42MM
GAMMA-BSM, BETA-BSM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
EGIA ULTRA UNIVERSAL STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·October 21, 2014
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011