10 results · 19ms · Sources: EU EUDAMED, US FDA

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CRANIOCUT

FDA 510(k)
FDA Class 2 ·Neurology

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500

FDA 510(k)
FDA Class 2 ·Cardiovascular

PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING

FDA 510(k)
FDA Class 2 ·Radiology

CADD MS3 CARTRIDGES

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·October 20, 2022

CONSTELLATION VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 20, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011

NELLCOR N-550 PULSE OXIMETER

FDA Adverse Event
Malfunction ·NELLCOR PURITAN BENNETT·Product code DQA·March 28, 2008

CENTRIMAG BLOOD PUMP

FDA Adverse Event
Injury ·THORATEC SWITZERLAND GMBH·Product code KFM·April 27, 2021

VERSYS FM HD 28X012/14

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 4, 2022

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