10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rotium Bioresorbable Wick
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Sensi-Disc™ Aztreonam 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316412·BD BBL™ Sensi-Disc™ Aztreonam 30 µg
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·November 14, 2008
ADVANTA II
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·August 24, 2011
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·July 12, 2013
BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 18, 2018