12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEETHAN 2.0
FDA 510(k)
FDA Class 2
·Physical Medicine
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103920·Large Cleaning Stylet
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321617160·
HVR PAIN RELIEF DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
PRESTIGE AMERITECH FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·March 31, 2020
AXIUM HELICAL DETACHABLE COIL
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·June 11, 2013
PORTEX BLUE LINE CUFFED ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code JOH·March 29, 2011
ROTABLATOR ROTALINK EXCHANGEABLE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MCX·September 9, 2008
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 26, 2022
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 10, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024