8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AVI MODEL 275CI INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Liofilchem MTS (MIC Test Strip)
FDA UDI
LIOFILCHEM SRL·18055182872289·
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
FDA 510(k)
FDA Class 2
·Cardiovascular
ENSPIRE DISCECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 17, 2013
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·December 6, 2010
ASSURITY DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 17, 2013