10 results · 23ms · Sources: EU EUDAMED, US FDA

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FLORASEAL, MODEL FS350D

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GLOBALCARDIO

FDA 510(k)
FDA Class 2 ·Cardiovascular

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E

FDA 510(k)
FDA Class 2 ·Anesthesiology

ELECTROSURGICAL COAGULATION FOR AESTHETIC

FDA Adverse Event
Injury ·F CARE SYSTEMS USA LLC·Product code ONQ·November 22, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 29, 2013

3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE

FDA Adverse Event
Injury ·3M HEALTH CARE·Product code KKX·April 20, 2011

ESPRIT VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 28, 2008

INFOV.A.C. THERAPY SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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