8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
KM-2 METAL-BACKED ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551208458·Bip. Forceps, 19 cm, bay., 0.5 mm
CAT 15-HEMATOLOGY & PATHOLOGY DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BHI AGAR
FDA 510(k)
FDA Class 1
·Microbiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 2, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 8, 2012
ARTERIAL CANNULA VENT CAP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·September 24, 2010
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