12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Through the Scope Tracheal Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
V SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDSOURCE IV ADMINSTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
TITAN
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·May 5, 2022
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
SYNCRHOMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 4, 2008
*
FDA Adverse Event
Malfunction
·MAQUET·Product code DTL·August 8, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·July 19, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025