BEUDAMED
    120 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    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

    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

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

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

    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

    FDA Enforcement
    Class II ·Terminated·Cochlear Americas Inc.·January 15, 2020

    Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 1, 2020

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

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 12, 2019

    Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R

    FDA Enforcement
    Class II ·Terminated·Krishe Inc·April 21, 2021

    Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·March 6, 2013

    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014

    Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,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

    Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).

    FDA Enforcement
    Class II ·Terminated·Medela Inc·January 8, 2020

    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

    FDA Enforcement
    Class II ·Terminated·Mani, Inc. - Kiyohara Facility·May 3, 2023

    Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·May 7, 2014