12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE KARL STORZ UROMAT(TM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150690·K-WIRE - SINGLE TROCAR 0.9mm DIA x 75mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122956·K-WIRE - SINGLE TROCAR 0.8mm DIA x 75mm
LORENZ SELF-DRILLING IMF SCREW
FDA 510(k)
FDA Class 2
·Dental
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATELLICA IM TOTAL HCG (THCG)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JHI·December 27, 2019
ATELLICA IM TOTAL HCG (THCG)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JHI·December 27, 2019
ESOPHYX 2-LINK
FDA Adverse Event
Malfunction
·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·January 23, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER - SILICON VALLEY·Product code GEX·December 22, 2010
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 17, 2014
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015