15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
FDA 510(k)
FDA Class 2
·Immunology
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026
BD BBL™ Sensi-Disc™ Erythromycin 15 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312902·BD BBL™ Sensi-Disc™ Erythromycin 15 µg
Sklar®
FDA UDI
SKLAR CORPORATION·10649111165337·SKLARLITE PRECIS SCIS 3.5 ST
ELMED
FDA UDI
ELMED INCORPORATED·00842180161030·PRISM CERVICAL CURETTE 10" ANGLED 90° 3-0, LIGH...
MODIFICATION TO EASYS TRANSVERSE CONNECTION
FDA 510(k)
FDA Class 2
·Orthopedic
IQ TECHNOLOGIES
FDA 510(k)
FDA Class 2
·Neurology
DRILL, AO, STERILE 4, 2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011
ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·March 11, 2026
ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·March 10, 2026
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·July 25, 2011
SURGIPRO II
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GAM·July 11, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022