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

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    Pelton & Crane Spirit 3000 dental chair (Model #SP30)

    FDA Recall
    Terminated ·Pelton & Crane Company·Product code NRU·March 4, 2011

    Pelton & Crane Spirit 1800 dental chair (Model #SP18)

    FDA Recall
    Terminated ·Pelton & Crane Company·Product code NRU·March 4, 2011

    The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: Marus MaxStar-Agency Model # DC1490; Marus MaxStar-Agency Model # DC1690; Marus NuStar-Agency Model # DC1700; Marus NuStar-Agency Model # DC1702; Marus ProStar-Agency Model # DC1540; Marus ProStar-Agency Model # DC1535; DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.

    FDA Recall
    Terminated ·Dental Equipment LLC·Product code NRU·March 23, 2010

    Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065 Product is labeled in part: DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17.

    FDA Recall
    Terminated ·Dental Equipment LLC·Product code NRU·March 1, 2011

    Alinity m Integrated Reaction Units (IRU)

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code OOI·February 11, 2022

    Alinity m Integrated Reaction Units (IRU)

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·March 9, 2022

    Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·January 25, 2008

    Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·January 25, 2008

    Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·August 8, 2006

    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KOI·April 9, 2014

    Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·October 15, 2010

    Mammotome MammoStar Biopsy Site Identified, REF STAR1401

    FDA Recall
    Terminated ·Carbon Medical Technologies, Inc.·Product code NEU·December 16, 2022

    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013

    HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

    FDA Recall
    Terminated ·Devicor Medical Products Inc·Product code NEU·March 30, 2022

    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013

    TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE

    FDA Recall
    Terminated ·Somatex Medical Technologies GmbH Rheinstr. 7 d Teltow Germany·Product code NEU·May 22, 2017

    Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.

    FDA Recall
    Terminated ·Kapp Surgical Instrument Inc·Product code NEU·May 24, 2011

    Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MRU·February 8, 2013

    Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.

    FDA Recall
    Terminated ·NRT Nordisk Rontgen Teknik A/S Birkegaardsvej 16 Hasselager Denmark·Product code JAA·May 1, 2009

    ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018