12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HYDROL
FDA 510(k)
FDA Class 2
·Dental
Spectrum, Inc.
FDA UDI
SPECTRUM, INC.·00850301007907·Strap-Stroll Stockinette, 6" X 6', Sterile
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110683·LUER ADAPTOR FOR IRRIGATION
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Medline Waste Station
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·April 7, 2014
MODEL 3000 30ML LOW FLOW PUMP
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF - RAYNHAM·Product code LKK·September 26, 2012
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 13, 2010
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·June 25, 2021
BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·August 2, 2021
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·July 1, 2021
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025