8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MARK III OXYGEN WALKER SYS. RESERVOIR
FDA 510(k)
FDA Class 2
·Anesthesiology
LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EXHALATION VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·February 14, 2014
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Injury
·PHYSIO-CONTROL, INC·Product code MKJ·November 14, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·September 3, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025