13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infusion Set for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
ANSWER HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304252776·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383561532·Gutta Percha Points is used to root canal filin...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383539944·Gutta Percha Points is used to root canal filin...
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOFLEX ROD
FDA 510(k)
FDA Class 2
·Orthopedic
NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·March 16, 2010
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·October 10, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 14, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013
NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·January 19, 2010
PEDICLE SCREW LATERAL CONNECTOR L150
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025