7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHOTAC-FIL APLICAP
FDA 510(k)
FDA Class 2
·Dental
TRI-MED QUICK-STEP GASTRIC LAVAGE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUP OUT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 18, 2014
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 22, 2013
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 14, 2010
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