65 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InMode VLaze
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCANSCOPE XT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TARGET DEVICE GAMMA3 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 13, 2012
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·March 29, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·March 29, 2024
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 23, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 15, 2014
NX3
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·June 17, 2013
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 20, 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
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
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 29, 2014
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·June 25, 2024
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·September 3, 2024
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·September 3, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·July 26, 2024
ACUSNARE POLYPECTOMY SNARE SOFT
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·April 8, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·June 7, 2024