BEUDAMED
    42 results · 31ms · 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 ×

    e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·May 15, 2012

    Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole-body scans, and SPECT studies.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·May 15, 2012

    D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Radial) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Application device consisting of an adjustable retention strap, collar and attached gauze pad.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code FRO·September 9, 2005

    Radionics Head and Neck Localilizer (HNL), Version B

    FDA Recall
    Terminated ·Radionics, Inc.·Product code MUJ·May 25, 2004

    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DXC·March 3, 2017

    QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF. Radial artery catheterization kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·February 10, 2003

    e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS--·September 5, 2003

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Recall
    Terminated ·Cook Inc.·Product code DYB·February 1, 2017

    Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LKJ·June 24, 2010

    BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code PQK·April 12, 2019

    Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code BWN·December 18, 2013

    RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH. Cardiovascular artery catheterization kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1. Arterial access tray for radial artery catheterization set

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020-1. Cardiovascular catheter wire guide

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LKJ·February 24, 2010

    Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lead Technologies Division, Minneapolis, MN 55439 USA.

    FDA Recall
    Terminated ·Enpath Medical, Inc·Product code DTB·July 18, 2006

    Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use.

    FDA Recall
    Terminated ·Enpath Medical, Inc·Product code DTB·July 18, 2006

    Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Recall
    Terminated ·Hand Biomechanics Lab Inc·Product code JEC·September 14, 2016

    Mevatron K2, camera imaging system, Part Number: 1940753; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS Henkestrasse, Erlangen, GERMANY The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc Radiation Oncology·Product code IYE·November 4, 2010