7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380
FDA 510(k)
FDA Class 1
·Anesthesiology
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AIR-FLOW PLUS Prophylaxis powder
FDA 510(k)
FDA Class 1
·Dental
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 13, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 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