11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707036043·WEB I MOL BANDS G8421-16+G2820-00 LR 24
Excel Cooley Blade
FDA UDI
KOROS U.S.A., INC.·10840199538635·Excel Cooley Blade 34mm Deep
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756655606·BASIC FOOT PACK
SARNS VENT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
FDA 510(k)
FDA Class 2
·Anesthesiology
VerSys®
FDA UDI
Zimmer, Inc.·00889024143722·
SYMBIQ DCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 15, 2014
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 4, 2013
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020