8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ABUSCREEN (R) EIA CANNABINOIDS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GIRAFFE AND PANDA WARMER
FDA 510(k)
FDA Class 2
·General Hospital
DELTA CER FEM HD 28/0MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code OQG·May 27, 2021
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·June 2, 2014
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·October 11, 2010
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·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