BEUDAMED
    52 results · 20ms · 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 ×

    BD K-3000 Microkeratome Blade REF 378607

    FDA Recall
    Terminated ·BD Opthalmic Systems·Product code HMY·January 24, 2003

    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code LMF·April 3, 2012

    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Recall
    Terminated ·Oscor, Inc.·Product code IKD·March 31, 2017

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Recall
    Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

    VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

    FDA Recall
    Terminated ·Product code JDK·September 19, 2007

    LIFEPAK 20 automatic external defibrillator

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code LDD·March 16, 2006

    Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·November 17, 2008

    standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code LDD·September 2, 2005

    Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·April 16, 2008

    DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code JDK·January 27, 2011

    QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.

    FDA Recall
    Terminated ·Medtronic Emergency Response Systems, Inc.·Product code LDD·September 2, 2005

    External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·November 17, 2008

    Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·May 13, 2008

    DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code JDK·January 27, 2011

    Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020

    FDA Recall
    Open, Classified ·Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom·Product code LDD·May 8, 2023

    VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

    FDA Recall
    Terminated ·Product code JDK·September 19, 2007

    LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.

    FDA Recall
    Terminated ·Laerdal Medical Corporation·Product code LDD·April 29, 2005

    R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505. This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.

    FDA Recall
    Terminated ·ConMed Corporation·Product code LDD·March 9, 2011

    The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·December 30, 2008

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code LBK·January 7, 2013