9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
OXF UNI TIB TRAY SZ C RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·November 22, 2022
OXF TWIN-PEG CMNTD FEM MD PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·November 22, 2022
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·February 5, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 3, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 18, 2014
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013