BEUDAMED
    35 results · 25ms · 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.

    PATIENT POSITIONING SYSTEM 1D OR 2D

    FDA 510(k)
    FDA Class 1 ·Radiology

    Mini Tweed

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746113765·DB BKT MINI TWEED UNIV CUSP 022 T=0 A=0 R=0

    ACUMED

    FDA UDI
    Acumed LLC·10806378040597·Plate Clamp

    RAZOR

    FDA UDI
    Ortho Arch Company Inc·D90980022312·RAZOR HARD WIRE CUTTER

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209100699·KIT, INDIVIDUAL PATROL OFFICER - CG - CHITOGAUZE

    Buratto LASIK Cannula, 23ga

    FDA UDI
    KATALYST SURGICAL LLC·00817489029961·

    NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ZURA TEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROGRAMMING COMPUTER

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 8, 2014

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKI·August 1, 2013

    Beckman Coulter Lipase, REF OSR6130 and OSR6230.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·August 24, 2018

    Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·August 24, 2018

    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·June 9, 2014

    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·April 13, 2016

    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·April 13, 2016

    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016

    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016