23 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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StimOnTM Pain Relief System (GM2439)
FDA 510(k)
FDA Class 2
·Neurology
RIGIDFIX
FDA UDI
DEPUY MITEK, LLC·10886705003150·RIGIDFIX TIBIAL BTB GUIDE BLOCK
CADD
FDA UDI
ICU MEDICAL, INC.·00610586017004·
CADD
FDA UDI
ICU MEDICAL, INC.·10610586017018·
ESCALATE LAMINOPLASTY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FRC POSTEC
FDA 510(k)
FDA Class 1
·Dental
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025
HUDSON VENTILATOR TUBING SET, LONG LENGTH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·November 7, 2013
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025
HUDSON VENTILATOR TUBING SET,LONG LENGTH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·December 2, 2021
HUDSON VENTILATOR TUBING SET,LONG LENGTH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·December 2, 2021
HUDSON VENTILATOR TUBING SET,LONG LENGTH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·December 2, 2021
HUDSON VENTILATOR TUBING SET,LONG LENGTH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·December 2, 2021
HUDSON VENTILATOR TUBING SET,LONG LENGTH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·December 2, 2021
ITREL II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 22, 2008
CAST CUTTER, 8 FOOT CORD"
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HAB·August 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
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