9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wireless TENS & EMS Unit
FDA 510(k)
FDA Class 2
·Physical Medicine
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857370029·Trial, Size 12x14x12 mm, 30°
Sonosite PX Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ZeptoLink IOL Positioning System
FDA 510(k)
FDA Class 2
·Ophthalmic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
STOCKERT SIII
FDA Adverse Event
Malfunction
·COBE CARDIOVASCULAR, INC.·Product code DWB·November 18, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025