BEUDAMED
    26 results · 12ms · Sources: EU EUDAMED, US FDA

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    Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 8, 2012

    Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

    FDA Recall
    Terminated ·Hobbs Medical, Inc.·Product code FDX·May 1, 2018

    Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract. REF: 5030 and 5030S

    FDA Recall
    Terminated ·Hobbs Medical, Inc.·Product code KOG·March 15, 2006

    Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5481490-2, 5911000-3); J. 3-0T MR750 32 CHANNEL (5352293); K. 3-0T MR750W FUTURE GEM CAPABLE (5352293, 5911000-3, 5499460-7); L. 3-0T MR750W GEM (5495558, 5352293); M. 3-0T MR750W GEM ENABLED (5911000-3, 5352293, 2394952-100, 5481490-2, 5499460-7, 5373011-3, 5495558, 5481490, 5396469-3, 5481490-3); N. 3-0T MR750W GEM ENABLED PLUS (5911000-3, 5352293, 5499460-10, 5481490-2); O. 3-0T MR750W NON GEM (5911000-3); P. 3T 750W (5921000-2, 5911000-3, 5396469-3, 5352293, 5481490-2, 5481490-3); Q. DISCOVERY MR 750W 3.0T (5481490-2, 5911000-3, 5499460-10); R. DISCOVERY MR750W (5911000-3); S. DISCOVERY MR750W 3 (5481490-2, 5911000-3); T. DISCOVERY MR750W 3T (5911000-3, 5396469-3, 5373011-3, 5481490-2); U. DISCOVERY MR750W GEM (5396469-3, 5352293); V. DISCOVERY MR750W WITH GEM (5911000-3); W. MR 3.0T MR750 W (5352293); X. MR 3.0T MR750W GEM ENABLED (5911000-3, 5352293); Y. MR 3-0T MR750W (5911000-3); Z. MR DISCOVERY 750W GEM (5911000-3); AA. MR OPTIMA MR750W 3.0T (5911000-3); BB. MR750W (5911000-3); CC. MR750W GEM ENABLED (5911000-3, 5499460-7); DD. MR750W GEM ENABLED PLUS (5352293); EE. MR750W PGR 32-CHANNEL (5911000-3); FF. 3.0T MR750W GEM ENAB (5911000-3) Product Usage: The Discovery MR750w 3.0T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance..

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·June 6, 2018

    ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·April 25, 2013

    Powered stretcher chair used during facial and eye surgeries. One chair per package.

    FDA Recall
    Terminated ·TransMotion Medical Inc·Product code GBB·November 14, 2014

    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBB·April 8, 2016

    Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBB·November 30, 2009

    Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.

    FDA Recall
    Terminated ·Medtronic Powered Surgical Solutions·Product code HBB·June 29, 2005

    Anspach Single Use, Sterile Bone Cutting Burrs

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·May 18, 2007

    Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)

    FDA Recall
    Terminated ·Medtronics Midas Rex·Product code HBB·November 11, 2002

    Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.

    FDA Recall
    Terminated ·Medtronic Powered Surgical Solutions·Product code HBB·May 30, 2008

    Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBB·April 28, 2016

    Medtronic Midas Rex Legend High Speed Pneumatic System

    FDA Recall
    Terminated ·Power Surgical Solutions·Product code HBB·November 11, 2004

    ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·November 28, 2012

    ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·November 28, 2012

    Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas

    FDA Recall
    Terminated ·Power Surgical Solutions·Product code HBB·November 3, 2004

    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HBB·September 1, 2017

    ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·November 28, 2012