13 results · 34ms · Sources: EU EUDAMED, US FDA

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STERISIL ANTIMICROBIAL TUBING AND BOTTLE

FDA 510(k)
FDA Class 1 ·Dental

POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MICROPAQ, MODELS 402, 404

FDA 510(k)
FDA Class 2 ·Cardiovascular

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code FSA·April 2, 2013

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·February 24, 2011

MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·April 18, 2008

WHITE STAR HIGH SPEED VIT CUTTER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

WHITE STAR HIGH SPEED VIT CUTTER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

SMARTNAIL

FDA Adverse Event
Injury ·CONMED CORPORATION·Product code MAI·July 29, 2019

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022

GLIDESHEATH

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021

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