7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
FDA 510(k)
FDA Class 2
·Radiology
PONTOR MPF,V-GNATHOS PF,24K CASTING GOLD
FDA 510(k)
FDA Class 2
·Dental
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 18, 2014
SIGMA STAB XLK INS 3 12.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 22, 2013
#7 SCORPIO 4:1 CERAMIC BLOCKS
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·November 23, 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