7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EAR APPLICATOR, CATALOG NO. 2229
FDA 510(k)
FDA Class 1
·General Hospital
BAG, URINARY, DRAINAGE, 2D9013
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cardinal Health Non-Reinforced Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2014
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 15, 2010
OXINIUM
FDA Adverse Event
Injury
·SMITH&NEPHEW, INC·Product code JDH·December 12, 2012
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