7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OXYGEN CONSERVATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
Quantum Workstation
FDA 510(k)
FDA Class 2
·Cardiovascular
VASCUTRAK PTA DILATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MBT TRAY SLEEVE POR M/L 29MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code NJL·June 10, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 11, 2010
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 10, 2012
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