11 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENGSTROM CARESTATION, ENGSTROM PRO
FDA 510(k)
FDA Class 2
·Anesthesiology
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959043893·ComfortGel Blue Full Mask, Large, Japan
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 21, 2022
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
FDA 510(k)
FDA Class 2
·Cardiovascular
SABRE COMPAC
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 24, 2021
PERCUTANEOUS INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 29, 2013
TRUETRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 4, 2011
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DRUAFLO TREATMENT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·July 22, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MGB·November 25, 2025