8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXAM GOWN
FDA 510(k)
FDA Class 1
·General Hospital
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515199101·Bone File, #12CA, DE, 5mm & 7mm, 7"
REVOLIX 120
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Nio Color 5.8MP (MDNC-6121)
FDA 510(k)
FDA Class 2
·Radiology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2007
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 5, 2014
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 3, 2012
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