8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ELIAS CARDIOLIPIN IGM ANTIBODIES
FDA 510(k)
FDA Class 2
·Immunology
SeaSpine Spacer System - Ventura™
FDA UDI
Seaspine Orthopedics Corporation·10889981033477·Fixed Ventura Trial, 9mm x 28mm x 12mm
WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE
FDA 510(k)
FDA Class 1
·Hematology
IMMEDIATE STABILIZING IMPLANT (ISI)
FDA 510(k)
FDA Class 2
·Dental
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 2, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2012
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024