11 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PRE-TIED LOOP SUTURE CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 27, 2018
TheraSphere Administration Accessory Kit (US)
FDA UDI
BIOCOMPATIBLES UK LTD·05060116922073·For use with a TheraSphere Administration Set t...
TheraSphere Administration Accessory Kit
FDA UDI
BIOCOMPATIBLES UK LTD·05060116920246·For use with a TheraSphere Administration Set t...
MP/S SINGLE WAVELENGTH MINI PHOTOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EMIT 2000 PROCAINAMIDE CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COULTER® ACT DIFF 2¿ ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·January 22, 2013
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
IDENTITY ADX XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 10, 2014
TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion
447 March Road
Ottawa Canada Ontario·Product code NAW·February 24, 2009
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020