8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LARYNGOSCOPE BLADES/HANDLES & LAMPS
FDA 510(k)
FDA Class 1
·Anesthesiology
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18056099649186·AGILE NAIL TI PEG SCREW L55MM D3.2MM STERILE
ELECTROSURGICAL TIP CLEANER & HOLDER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·March 25, 2014
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO KG·Product code NVZ·November 5, 2012
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Death
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·September 7, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018