7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SD TL Implant System
FDA 510(k)
FDA Class 2
·Dental
MAMMOTOME MR BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
iHealth Wireless No-Touch Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 11, 2014
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
T-PAL SPACER APPLICATOR INNER SHAFT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025