11 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sentinella 102, Sentinella 102 Horus
FDA 510(k)
FDA Class 1
·Radiology
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776118617·Universal Keyhole Bracket, 14 position
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776021719·Universal Keyhole Bracket
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776115807·Universal Keyhole Bracket
CAREFUSION NICOLET EDX
FDA 510(k)
FDA Class 2
·Neurology
LMT NOMAG IC 3.0
FDA 510(k)
FDA Class 2
·General Hospital
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776023126·Universal Keyhole Bracket
COYOTE? ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·October 10, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2011
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026