7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERITONEAL/CARDIAC CATHETER
FDA 510(k)
FDA Class 2
·Neurology
NIOX VERO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 15, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·January 6, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
AQUATEC OPERATIONS GMBH·Product code IKX·July 31, 2014
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018