8 results
·
35ms
·
Sources: EU EUDAMED, US FDA
ULTRACHEM T-BILI 64971 GILFORD 3500
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EEG-Now
FDA 510(k)
FDA Class 2
·Neurology
CENTURION SORBAVIEW OTC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WALKMED® 150 ML RESERVOIR BAG
FDA Adverse Event
Malfunction
·WALKMED TECHNOLOGIES, LLC·Product code FRN·September 5, 2025
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 7, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 16, 2007
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