BEUDAMED
    57 results · 21ms · 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 × Status: Terminated × Clear all

    Merge PACS

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·August 6, 2020

    Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplies, forms, and instructions. Blood specimen collection

    FDA Recall
    Terminated ·Heritage Labs International LLC·Product code LCP·January 9, 2011

    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code GWF·September 27, 2010

    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code GWF·September 27, 2010

    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code GWF·September 27, 2010

    Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·May 8, 2020

    Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.

    FDA Recall
    Terminated ·Aperio Technologies Inc·Product code IBM·February 22, 2013

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    FDA Recall
    Terminated ·Iba Dosimetry·Product code IYE·April 26, 2017

    "***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B143004666. Product Usage: Cutting and shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HTT·May 19, 2008

    Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sulz a.N. Germany Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator.

    FDA Recall
    Terminated ·VBM Medical Inc.·Product code BTO·May 9, 2011

    Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sul z a.N. Germany Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator.

    FDA Recall
    Terminated ·VBM Medical Inc.·Product code BTO·May 9, 2011

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Recall
    Terminated ·BioMedical Equipment Service Co (BMES)·Product code FRN·February 25, 2021

    Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-203

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBM·March 17, 2003

    Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

    FDA Recall
    Terminated ·Apogee Medical, Inc·Product code GBM·July 17, 2008

    Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

    FDA Recall
    Terminated ·Apogee Medical, Inc·Product code GBM·July 17, 2008

    Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBM·March 17, 2003

    Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

    FDA Recall
    Terminated ·Apogee Medical, Inc·Product code GBM·July 17, 2008

    Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DBM·April 12, 2004

    SpeediCath , SpeediCath with Accessories Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark 284821 1400 SpeediCath, acc CH10 Male 284831 1400 SpeediCath, acc CH12 Male 284841 1400 SpeediCath, acc CH14 Male 284851 1400 SpeediCath, acc CH16 Male 284861 1400 SpeediCath, acc CH18 Male 284811 1400 SpeediCath, acc CH8 Male 285011 1400 SpeediCath,acc CH10 Female 285021 1400 SpeediCath,acc CH12 Female 285031 1400 SpeediCath,acc CH14 Female 285041 1400 SpeediCath,acc CH16 Female 284991 1400 SpeediCath,acc CH6 Female 285001 1400 SpeediCath,acc CH8 Female The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with post void a residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urin to drain. The insertion supplies provided are to be used to insert the catheter using sterile technique.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code GBM·April 21, 2011

    Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code GBM·March 17, 2003