11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERTEX SPINAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
FDA 510(k)
FDA Class 2
·Cardiovascular
REALSEAL XT SEALER
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 17, 2024
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M).RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·October 19, 2023
UNKNOWN METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2017
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·May 21, 2013
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·June 13, 2011
HDNDL-E 22 X 1/2 IN I BLUE 11M
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code FMI·August 14, 2008
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021