10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERSA-CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
BOTTLE BREATHING DEVICE
FDA 510(k)
FDA Class 1
·Anesthesiology
ISODYNE
FDA 510(k)
FDA Class 1
·Dental
FULL-SIZE LID W/RETENTION PLATE SILVER
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code FRG·March 10, 2016
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 5, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 23, 2007
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024