9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983049·posteriors; shade B2; size XL; lower jaw
Reliance Lumbar IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
TORNADO ROTATABEL SNARE AND POLYP CATCHER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Zimmer, Inc.·00889024218376·
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 28, 2013
OPTICROSS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·August 6, 2014
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·February 4, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024