12 results · 21ms · Sources: EU EUDAMED, US FDA

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BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD BBL™ Sensi-Disc™ Cefaclor 30 µg

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316535·BD BBL™ Sensi-Disc™ Cefaclor 30 µg

DATEX-OHMEDA HMEF 750

FDA 510(k)
FDA Class 2 ·Anesthesiology

LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

COROX OTW 75-UP STEROID

FDA Adverse Event
Injury ·BIOTRONIK GMBH & CO.·Product code MRM·November 14, 2008

UROMAX ULTRA¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code EZN·September 1, 2011

URETEX SUPPORT PP KIT X1

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·July 12, 2013

KIDS OXYGENATOR D101

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025

BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022