9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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dS Breast Coil 7ch 1.5T
FDA 510(k)
FDA Class 2
·Radiology
BD SAFETYGLIDE¿ THIN WALL; 8MM LENGTH, 31G
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·May 17, 2016
Circular Fixation with Balanced Cable Transport
FDA 510(k)
FDA Class 2
·Orthopedic
XIO RADIATION TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TRIMA ACCEL PLT, PLS, RBC SET
FDA Adverse Event
Malfunction
·CARIDIANBCT·Product code LKN·July 19, 2011
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 6, 2014
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 18, 2013
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·March 4, 2020
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025