11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304214101·
6450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136025704·6450 DISP MEDIUM W/HG MGC MADPT
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837066833·7mm Rasp / Trial, No Tabs
RUSCH MEMORY BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WITHINGS BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
INTELLIVUE MX500 PATIENT MONITOR
FDA Adverse Event
Death
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·May 8, 2013
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·AVENT S. DE R.L. DE C.V.·Product code HEB·September 24, 2014
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·May 18, 2011
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025