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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
DG Reader
FDA UDI
DIAGNOSTIC GRIFOLS SA·08437014205176·The DG Reader is a device designed to read, int...
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
FDA 510(k)
FDA Class 2
·General Hospital
CONELOG IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BASIX COMPAK INFLATION SYRINGE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 27, 2011
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 8, 2023
SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE
FDA Adverse Event
Injury
·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·October 28, 2008
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 17, 2011
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code FTL·July 3, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019