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

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FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE

FDA 510(k)
FDA Class 2 ·Dental

Ultra-Pro e™ Variable Angle Needle Guide

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101957·Sterile needle guide with (14 x 91.5cm) telesco...

BD SYRINGE 3ML LL 200 S/C

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 11, 2025

HDL-CHOLESTEROL PLUS 2ND GENERATION

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PERIFIX SAFETY EPIDURAL NEEDLES

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD SYRINGE 3ML LL 200 S/C

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 11, 2025

BD SYRINGE 3ML LL 200 S/C

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 23, 2025

INTRALASE FS2

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·April 29, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

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

CELL-DYN WBC REAGENT A

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·July 29, 2008

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018