BEUDAMED
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    MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105633·PowerChem Neoprene Exam Gloves, Medium

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium

    Orthopedic manual surgical instrument

    FDA UDI
    BAUI BIOTECH CO. LTD.·04710577043404·Extending Tube

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450755747·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450775301·

    SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE

    FDA 510(k)
    FDA Class 2 ·Dental

    SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    M-H HA/PC 11X160MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·December 16, 2015

    M-H SOLID SHELL HA/PC DIA54MM LN24

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·March 1, 2016

    MALLORY-HEAD SHORT FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·July 28, 2017

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·August 11, 2016

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    GAS MODULE III

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code BZK·April 30, 2013

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·May 5, 2011

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·August 1, 2008

    MLRY-HD XR LAT POR FMRL 8MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020

    LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT

    FDA Adverse Event
    ROCHE MOLECULAR SYSTEMS·Product code OOI·July 11, 2012