15 results · 20ms · Sources: EU EUDAMED, 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