8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CAMSYS 6300
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TISSUELINK BIPOLAR FLOATING BALL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAMILTON-C1
FDA 510(k)
FDA Class 2
·Anesthesiology
THORATEC PVAD
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 17, 2013
UNK
FDA Adverse Event
Malfunction
·UNK·Product code FWM·December 7, 2010
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·October 8, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021