12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLARUS (700)
FDA 510(k)
FDA Class 2
·Ophthalmic
BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·January 13, 2022
BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·January 13, 2022
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Aevumed RAPID Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2024
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 11, 2023
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 11, 2014
CVC SET: 3-LUMEN 7FR X 2 0CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·August 24, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2013
BD LUER-LOK¿ TIP SYRINGE ONLY
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 23, 2023
SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·October 17, 2023