11 results
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28ms
·
Sources: EU EUDAMED, US FDA
ARDENT NON GAMMA-2 70
FDA 510(k)
FDA Class 2
·Dental
PARAPOST XT SYSTEM
FDA 510(k)
FDA Class 1
·Dental
I.V. START KIT (AHC-50-54954
FDA 510(k)
FDA Class 1
·General Hospital
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018
ZIMMER AIR DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·November 4, 2024
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 22, 2014
ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·February 15, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2010
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·March 8, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 11, 2016
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022