11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-ASSAY APO AI
FDA 510(k)
FDA Class 2
·Immunology
Edge™ Diamond BR033-4.5SC Barrel
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172007436·Diamond dental bur, reusable
artegral life
FDA UDI
Merz Dental GmbH·D7091993345·anteriors; shade C2; mould IS
Arthrex DynaNite Compression Plate
FDA 510(k)
FDA Class 2
·Orthopedic
ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.)
FDA 510(k)
FDA Class 2
·Dental
SYNERGY¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 4, 2015
EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 14MM RIGH
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code HRY·March 27, 2025
FETCH®2
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DXE·August 11, 2015
ASR XL TAP SLV ADAP 12/14+2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020