13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RISE SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
Y-Cable Top/Bottom Array 3T PH
FDA UDI
Noras MRI products GmbH·04251269203763·
Y-Cable Top/Bottom Array 3T PH
FDA UDI
Noras MRI products GmbH·04251269205323·
Y-Cable Top/Bottom Array 3T PH
FDA UDI
Noras MRI products GmbH·04251269205934·
Arx
FDA UDI
Life Spine, Inc.·00190837035464·ARX Rocker
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2023
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOINSIGHT
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·May 15, 2013
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 25, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021