7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
SPINAL SURGERY FRAME
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CHEROKEE MODEL 102A WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
AM CATH ESWL STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 19, 2010
PLATE, 8 HOLE JL
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·December 17, 2012
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015