8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CO2 Laser Therapy Systems (SHE-LSP003-1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·November 21, 2008
EPIC PLUS VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 23, 2013
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 26, 2024