9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Yushan X-Ray Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114025·HYDRO-DISSECT FLAT J-SHAPED 27GA (PK/10)
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
FDA 510(k)
FDA Class 2
·Microbiology
FEMALE ROTATING COLLAR
FDA Adverse Event
Injury
·Product code GAD·August 15, 2017
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 7, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011
CARESTREAM DRX-EVOLUTION FULL FEATURED WALL ST
FDA Adverse Event
Malfunction
·CARESTREAM HEALTH, INC.·Product code KPR·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025