8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HEPARIN COATED BALLOON THERMODILU
FDA 510(k)
FDA Class 2
·Cardiovascular
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18056099648868·AGILE NAIL TI LOCKING SCREW L36MM D4MM STERILE
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9600
FDA Adverse Event
GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2010
SPINE - ROD
FDA Adverse Event
Injury
·Product code HSB·November 15, 2012
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 27, 2014
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015