9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EndoGator Endoscopy Irrigation Tubing
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·March 13, 2019
NERIA MULTI SUBCUTANEOUS INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NRG TRANSSEPTAL NEEDLE
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·December 22, 2020
LINEAR LEAD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 4, 2008
ECHELON 60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 23, 2011
CURRENT PLUS VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025