7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SPECTRON PRIMARY STEM FEMORAL PROSTHES
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPORARY CEMENT-DC010002
FDA 510(k)
FDA Class 2
·Dental
Lavieen
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 10, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 8, 2015
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE LLC.·Product code NDN·August 26, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024