7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
OSTEO STEINMANN PIN
FDA 510(k)
FDA Class 2
·Orthopedic
TRAXX ELECTRIC WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STELLARIS 23G VITRECTOMY CUTTER
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·May 23, 2014
HUDSON MICRO MIST NEBULIZER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·January 16, 2013
INSYNC MAXIMO
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010
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