7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ANABAG
FDA 510(k)
FDA Class 1
·Microbiology
RID PLATES & INTENSI. FOR HUMAN IGE ETC
FDA 510(k)
FDA Class 2
·Immunology
KARL STORZ ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
RIGHT TOTAL HIP REPLACEMENT/ACCOLADE TMZF
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·October 13, 2010
OT PING 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