BEUDAMED
    457 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.

    FDA Recall
    Open, Classified ·The Binding Site Group, Ltd.·Product code OTA·April 16, 2026

    SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DIS·June 12, 2019

    (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

    FDA Recall
    Terminated ·Leventon S. A. U. Calle Newton 18 24 Sant Esteve Sesrovires Barcelona Spain·Product code MEB·May 23, 2019

    Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.

    FDA Recall
    Terminated ·Estill Medical Technologies, Inc·Product code BSB·July 25, 2014

    Esaote brand Formul@ ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand ArchiWin Colour ECG System; part 9704325000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand Archimed 4220 ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand Formula for Archimed ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Recall
    Terminated ·LivaNova USA·Product code DWC·April 20, 2018

    ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code CIC·October 22, 2021

    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code JBS·June 23, 2015

    NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709.

    FDA Recall
    Terminated ·Ohio Medical Corporation·Product code BTA·May 10, 2010

    Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.

    FDA Recall
    Terminated ·Medela AG Medical Technology Lattichstrasse 4b Baai Switzerland·Product code BTA·December 2, 2020

    SSCOR Suction Device Model 2310V

    FDA Recall
    Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

    SSCOR Suction Device Model 2310BV

    FDA Recall
    Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

    Easy Go Vac Aspirator, Model PM65HG. Portable suction unit

    FDA Recall
    Terminated ·Precision Medical, Inc.·Product code BTA·November 9, 2004