24 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMY Medical Therapy Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334009120·Otis bougie-a-boule. stainless steel
Hexalobe Driver
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039875·
EASY ON-PC SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
RADIOGRAPHIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II, PreciControl Anti-HBs
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II, PreciControl Anti-HBs
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs / Elecsys HBs II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II, PreciControl Anti-HBs
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBs II, PreciControl Anti-HBs
MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET
FDA Adverse Event
Injury
·COOK INC·Product code KNT·November 10, 2021
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 18, 2013