BEUDAMED
    268 results · 14ms · Sources: EU EUDAMED, US FDA

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    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Recall
    Terminated ·Product code FPA·November 7, 2014

    Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·September 30, 2015

    Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·September 11, 2019

    Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FRN·January 19, 2007

    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·January 26, 2022

    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.

    FDA Enforcement
    Class II ·Terminated·Cellestis Inc·March 6, 2013

    Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·January 30, 2019

    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code JKA·December 9, 2021

    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.

    FDA Enforcement
    Class II ·Terminated·Abbott·April 22, 2020

    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.

    FDA Recall
    Terminated ·Abbott·Product code NIK·February 28, 2020

    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NIK·August 28, 2017

    VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.

    FDA Recall
    Terminated ·Cellestis Inc·Product code NCD·September 27, 2012

    St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code KRG·October 6, 2006

    Merlin PCS programmer (Model # 3650), Software (Model # 3330)

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code OSR·April 16, 2018

    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code MXC·April 16, 2018

    Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

    FDA Recall
    Terminated ·Cook Inc.·Product code PYC·April 9, 2019

    Merlin PCS programmer (Model # 3650), Software (Model # 3330)

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018