BEUDAMED
    2,829 results · 27ms · 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 Regulation: Us FDA ×

    SFXSPI PDS+ UNI VIO 18IN 3-0 SA PS-2 PR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code NEW·January 13, 2026

    SFXSPI MCL+ UNI UD 27IN 3-0 SA PS-2 PR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·February 18, 2026

    SFXSPI MCL+ BI UD 12IN2 3-0 DA PS-2 PR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·January 15, 2025

    SFXSPI PDS+ UNI VIO 27IN 3-0 SA PS-2 PR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·February 4, 2025

    SFXSPI PDS+ UNI VIO 18IN 3-0 SA PS-2 PR

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code NEW·January 23, 2025

    ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code JJI·January 2, 2007

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

    CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code MOI·June 9, 2006

    ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code MMI·December 21, 2005

    ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DDR·October 17, 2005

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 26, 2013

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·April 24, 2014

    ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code CEP·November 22, 2006

    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DBF·June 6, 2006

    ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code MMI·March 8, 2007

    XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DIF·June 27, 2005

    IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code NRP·August 11, 2006

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    FDA Recall
    Terminated ·Mar-Med Co·Product code GAX·December 28, 2020

    ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code CGN·March 11, 2005

    ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code LIG·March 8, 2006