BEUDAMED
    33 results · 30ms · Sources: EU EUDAMED, US FDA

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    Picasso/Picasso Lite lasers Intended use: Dentistry.

    FDA Recall
    Terminated ·AMD Lasers, LLC·Product code GEX·April 15, 2010

    PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the eye.

    FDA Recall
    Terminated ·Alcon Laboratories, Inc.·Product code HQF·September 26, 2008

    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code CIJ·July 10, 2020

    Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent

    FDA Recall
    Terminated ·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JFJ·July 10, 2020

    Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·May 12, 2020

    STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code OEZ·November 2, 2022

    Magnesium on RX Imola analyser IVD

    FDA Recall
    Terminated ·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JGJ·April 14, 2016

    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

    FDA Recall
    Terminated ·Alcon LenSx, Inc. 33 Journey Aliso·Product code OOE·March 14, 2014

    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020

    Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery

    FDA Recall
    Completed ·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015

    Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery

    FDA Recall
    Completed ·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015

    Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJI·February 27, 2015

    Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·March 17, 2005

    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJL·October 25, 2012

    Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.

    FDA Recall
    Open, Classified ·Haag-Streit USA Inc·Product code HJO·April 15, 2021

    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HRS·October 20, 2015

    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HRS·October 20, 2015

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·January 6, 2014

    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

    FDA Recall
    Open, Classified ·Tornier, Inc·Product code KWS·June 12, 2023