8 results
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25ms
·
Sources: EU EUDAMED, US FDA
MEDSENTRY FLOTATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PROLENE Soft Polypropylene Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLAROS DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATTAIN ABILITY STRAIGHT
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
ADAPTA SR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·October 9, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·December 10, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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