19 results · 24ms · Sources: EU EUDAMED, US FDA

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HARMONIE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT

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

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT

FDA 510(k)
FDA Class 2 ·Cardiovascular

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·January 4, 2016

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTL.·Product code MNI·September 16, 2011

APASS LP

FDA Adverse Event
Other ·MEDICREA INTERNATIONAL·Product code MNI·June 15, 2011

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP

FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·April 29, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 10, 2011

EASY-OUT

FDA Adverse Event
Other ·ARTHREX, INC.·Product code LXH·July 24, 2008

PASS LP

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022

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