9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PUNCTURE KIT, INTERNAL JUGULAR
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515199040·Bone Rasp, #64, 3mm & 4mm DE, 7"
KARL STORZ ShuntScope
FDA 510(k)
FDA Class 2
·Neurology
XPERT MRSA
FDA 510(k)
FDA Class 2
·Microbiology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
HEARTSTART XL+DEFIBRILLATOR/MONTIOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 5, 2014
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·October 3, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
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