8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CHE
FDA 510(k)
FDA Class 1
·Microbiology
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581361100001·A-FIT® 1. MOLAR LWR LFT SZ 11
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAPID PROGRAMMER
FDA 510(k)
FDA Class 2
·Neurology
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·May 15, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 25, 2010
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026