8 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
FDA 510(k)
FDA Class 2
·Neurology
CONCORDE Bullet Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KOG·September 16, 2011
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·November 6, 2014
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 29, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025