12 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTEGRA-T
FDA 510(k)
FDA Class 2
·Orthopedic
BICONITE SURFACE TREATMENT
FDA 510(k)
FDA Class 2
·Dental
RANDOX LIPOPROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
US CATHENA 20GX1.00IN STRAIGHT BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 11, 2025
US CATHENA 20GX1.00IN STRAIGHT BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 11, 2025
US CATHENA 20GX1.00IN STRAIGHT BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 14, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 13, 2011
ZERO TIP NITINOL STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·July 25, 2008
PVA FOAM EMBOLIZATION PARTICLES
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 26, 2018
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023