13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITA IN-CERAM YZ CUBES FOR CEREC
FDA 510(k)
FDA Class 2
·Dental
SYNERGY HA COATED POROUS FEMORAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
BARBITURATES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·May 15, 2026
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·May 15, 2026
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 24, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·April 3, 2008
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 17, 2019
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 27, 2025
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 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