11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Remi Custom Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981042103·35x27mm Trial Rasp 16mm 12 deg
VX1+
FDA 510(k)
FDA Class 2
·Cardiovascular
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
FDA 510(k)
FDA Class 2
·Radiology
TENDRIL SDX
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 11, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 27, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013
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 Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
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
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026