54 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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SECTRA MICRODOSE MAMMOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
n.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR61100251·Traction band with foam pad without facebow
OsteoMed
FDA UDI
OSTEOMED LLC·00845694039970·PrimaLIF 5mm Pituitary Rongeur, Up
OCS-B Collagen
FDA UDI
Nibec Co., Ltd.·08809186549509·OCS-B Collagen® is a combination of purified ca...
Straumann XenoFlex
FDA UDI
Nibec Co., Ltd.·08809186541770·Straumann XenoFlex® is a combination of purifie...
LEONE SPA
FDA UDI
LEONE SPA·08033707096894·BKT 25 INTERACTIVE SL 22 T-7 BH
ELECTRICATOR MODEL 26000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2022
RADICAL 7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·December 18, 2014
RADICAL 7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·December 18, 2014
Widex
FDA UDI
Widex A/S·05706069560060·Widex UNIQUE U-CIC (Light beige ) 110, Right, R...
Widex
FDA UDI
Widex A/S·05706069886832·WIDEX MOMENT M-XP (Light beige ) 110, Telecoil
Widex
FDA UDI
Widex A/S·05706069670387·Widex EVOKE E-XP (Light beige ) 110, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069558296·Widex UNIQUE U-XP (Light beige ) 110, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069673142·Widex EVOKE E-CIC (Light beige ) 110, Right, RC...
Widex
FDA UDI
Widex A/S·05706069888706·WIDEX MOMENT M-CIC (Light beige ) 110, Right
RADICAL-7 COLOR SCREEN HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·May 29, 2015
RDS3 DOCKING STATION
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 17, 2014