14 results · 22ms · Sources: EU EUDAMED, US FDA

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ZQUIET MOUTHPIECE

FDA 510(k)
FDA Class 2 ·Dental

LEONE SPA

FDA UDI
LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz

AT HOME DRUG TEST, MODEL 9084

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)

FDA 510(k)
FDA Class 2 ·Dental

CONTOUR PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024

BD Q-SYTE CLOSED LUER ACCESS DEVICE

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·April 26, 2024

CONTOUR PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013

EDWARDS SAPIEN TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·September 16, 2014

HUT EXT DR FINAL ASSY-REVERSE

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·April 12, 2011

CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

FDA Adverse Event
Malfunction ·AESCULAP, INC.·Product code GEI·April 15, 2015

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023

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