40 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QiF Blood and Fluid Warmer
FDA 510(k)
FDA Class 2
·General Hospital
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK112151·DD tempMED are pre-colored dental milling blank...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694032711·Oracle 15mm Cranial Distractor
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383552660·Gutta Percha Points is used to root canal filin...
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NUANCE
FDA 510(k)
FDA Class 2
·Dental
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 14, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·September 22, 2008
CADD PRIZM
FDA Adverse Event
Injury
·SMITHS MEDICAL·Product code FRN·September 19, 2006
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019
COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 19, 2019
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 20, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 2, 2020
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·February 10, 2020
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 12, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·January 16, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·February 3, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2020