10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SimpleStitch Suturing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369894·Trial, Size 12x14x14 mm, 20°
Straumann CARES P-Series CAD/CAM System
FDA 510(k)
FDA Class 2
·Dental
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 29, 2011
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·July 23, 2013
11.5MM MEDULLARY REAMER HEAD
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·April 8, 2020
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025