BEUDAMED
    25 results · 9ms · 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 Status: Terminated ×

    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Recall
    Terminated ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012

    COBAS TaqMan analyzer, Series 96; catalog number 8080216.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code JJF·March 6, 2003

    Cytomics FC500 with CXP Software

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JJF·November 23, 2005

    COBAS TaqMan 48 Analyzers.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code JJF·May 24, 2004

    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJF·February 1, 2012

    Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Recall
    Terminated ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012

    V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Recall
    Terminated ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·September 7, 2018

    Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **, Roche Diagnostics Corporation, Indianapolis 46250.(**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJF·August 30, 2007

    Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Recall
    Terminated ·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012

    COBAS TaqMan Analyzer

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code JJF·May 24, 2004

    Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJF·May 21, 2007

    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011

    Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·January 14, 2020

    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

    FDA Recall
    Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019

    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·April 24, 2012

    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code EJF·February 8, 2013

    Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·March 25, 2014

    Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484

    FDA Recall
    Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019