11 results · 21ms · Sources: EU EUDAMED, US FDA

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INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 2, 2024

TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ACUGLIDE BRAND ACUPUNCTURE NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

AUTOSOFT 90

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 21, 2025

LIAISON TREPONEMA ASSAY

FDA Adverse Event
Other ·DIASORIN S.P.A.·Product code LIP·April 8, 2013

CONMED NEONATAL ECG ELECTRODE W/LEADWIRE

FDA Adverse Event
Other ·CONMED CORPORATION·Product code DRX·July 22, 2008

MAXGUARD ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORPORATION·Product code FPA·April 27, 2011

SYRINGE 1ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 5, 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