10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NP Medical nCompass Extension Set with Stabilizing Base
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL™ Motility Indole Ornithine Medium, Deeps
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902215180·BD BBL™ Motility Indole Ornithine Medium, Deeps
PAINDOC
FDA 510(k)
FDA Class 2
·Neurology
Route 92 Medical 088 Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
LIFELINE AED
FDA Adverse Event
Malfunction
·DEFIBTECH, LLC·Product code MKJ·November 5, 2008
ENDO GIA ROTICULATOR 60-3.5 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·August 17, 2011
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code HSN·July 9, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025