44 results
·
22ms
·
Sources: EU EUDAMED, US FDA
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
FDA 510(k)
FDA Class 2
·Immunology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TERUMO U-100 INSULIN SYRING
FDA 510(k)
FDA Class 2
·General Hospital
PRECISION NOVI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 19, 2024
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 29, 2024
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Malfunction
·ETHICON, INC·Product code GAM·April 22, 2013
PINN MAR +4 10D 46ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 15, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 2, 2008
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 25, 2022
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·January 26, 2024
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·November 25, 2025
CAPIOX FX HOLLOW FIBER OXYGENATOR WITH HARDSHELL RESERVOIR, ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 10, 2023
CAPIOX FX25
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·July 18, 2023
CAPIOX FX15 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 3, 2025
CAPIOX CUSTOM PACK
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DTZ·June 10, 2023
CAPIOX CUSTOM PACK
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 10, 2023
CAPIOX FX15 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·January 25, 2023
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 23, 2022
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2022