9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Tecomet
FDA UDI
TECOMET INC.·00841435108325·SUTURE CUTTER
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756972901·CATARACT PACK
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
IFS PROFILE PLATES, SCREWS, AND WASHERS
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
ASAHI CONFIANZA PRO PTCA GUIDE WIRE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code DQX·January 28, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024