7 results
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23ms
·
Sources: EU EUDAMED, US FDA
VAS-CATH PERITONEAL DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Biodesign Diaphragmatic Hernia Graft
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OSTEOGRAF/N-300
FDA 510(k)
FDA Class 2
·Dental
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 13, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·October 16, 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