9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
FDA 510(k)
FDA Class 2
·Microbiology
INTEGRAL HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304208643·
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019
GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 2/12 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 3, 2021
QUADRANT ILLUMINATION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code FTY·June 11, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 14, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·October 10, 2014