13 results
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19ms
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Sources: EU EUDAMED, US FDA
MRI TOBRAMYCIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ReLine
FDA UDI
Nuvasive, Inc.·00195377017659·RELINE-C Screw, 3.5x16mm FA
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135160·Zip® Implant - 12 mm (STERILE) [6 PK]
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7402813516·Rampart-O
INVACARE ELEVATING SEAT OPTION ESS6
FDA 510(k)
FDA Class 2
·Physical Medicine
THERASOM-CAST
FDA 510(k)
FDA Class 2
·Dental
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
CAROTID WALLSTENT MONORAIL ENDOPROTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIM·August 24, 2010
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