10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TRAY, BLADDER IRRIGATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Daytona Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981161293·Connector Set Screw, Replacement
BLOOD-SMEARING INSTRUMENT (MINIPREP TM)
FDA 510(k)
FDA Class 1
·Hematology
CARTO RMT EP NAVIGATION SYSTEM V8
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 18, 2014
M2A-MAGNUM MODULAR HEAD 46MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 26, 2012
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 16, 2010
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025