10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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StealthFix Intraosseous Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
QuickLine Soft Reline Material 50ml cartridge, 12 mixing tips
FDA UDI
STERNGOLD DENTAL LLC·00841549118319·Long term soft relining material
IQ FLEX M
FDA Adverse Event
Malfunction
·FIRST SOURCE INC.·Product code IZL·May 29, 2024
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k)
FDA Class 1
·General Hospital
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
FDA 510(k)
FDA Unclassified
·Unknown
ELECTRIC PEN DRIVE 60,000 RPM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code DZI·August 16, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
ACCU-CHEK ® ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 1, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025