8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
OVONIC COATED SURGICAL SCISSORS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
UCSS® Screw Set
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978067872·BONE SCREW 873-046 4.0 CANN CORT L 46MM
Cocoon Portable Handheld X-Ray System
FDA 510(k)
FDA Class 2
·Dental
ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 13, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·December 13, 2012
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·October 14, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020