24 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
FDA 510(k)
FDA Class 2
·General Hospital
THERMOFLASH(TM) INFRARED THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SYNTHES MATRIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 22, 2014
LIBERTÉ?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·June 27, 2013
TUNNELING TOOL, 12"
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 19, 2011
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 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
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 5, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
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