16 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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VIDAS B.R.A.H.M.S. PCT ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ConMed Linvatec
FDA UDI
Provision·B504OM50711460·
NA
FDA UDI
STERILMED, INC.·10888551020466·SAW BLADE OSCILLATING LARGE BONE
CONMED
FDA UDI
Conmed Corporation·10845854008058·OSCILLATOR BLADE, 25 X 90 X 0.9 MM (.035")
D/SENSE 1-STEP
FDA 510(k)
FDA Class 2
·Dental
GENYX FLEXIBLE INJECTION NEEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 22, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 27, 2011
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
FREESTYLE INSULINX
FDA Adverse Event
Malfunction
·Product code NBW·April 10, 2013
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012