13 results · 28ms · Sources: EU EUDAMED, 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