BEUDAMED
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    LDH (L-P) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750000593·VITROS Chemistry Products UPRO Slides

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517134493·Helix R Plate, 20mm 1-Level

    THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope

    FDA UDI
    THD SPA·08033737710579·The THD Light-Scope rectoscope is a disposable ...

    ORTHO ARCH

    FDA UDI
    Ortho Arch Company Inc·D9098001201·MATHIEU NEEDLE HOLDER W/ SAFETY LATCH - FINE TIP

    ACUMED

    FDA UDI
    Acumed LLC·10806378040030·Universal Tray Base

    Opaque

    FDA UDI
    Kerr Corporation·00841396107962·Resin Based Dental Restorative Material - C2

    PENILE IMPLANT

    FDA Adverse Event
    Injury ·DACOMED·Product code FAE·February 15, 1995

    Electrode

    FDA UDI
    SOPRO-COMEG GmbH·04059082009728·

    PRO-TORQ

    FDA 510(k)
    FDA Class 1 ·Dental

    HFO SHOULDER COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DURAPHASE PENILE PROSTHESIS, CYLINDER BODUS

    FDA Adverse Event
    Malfunction ·DACOMED CORP.·Product code FAE·May 13, 1994

    530G INSULIN PUMP MMT-751NAH

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2018

    OT ULTRA EASY METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS, LLC/IKARIA·Product code MRN·August 10, 2010

    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·February 15, 2017

    HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR120V

    FDA Adverse Event
    Malfunction ·CONMED LARGO·Product code GEI·August 11, 2023

    Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.

    FDA Recall
    Terminated ·Biokit U.S.A. Inc.·Product code LGC·April 14, 2010

    VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 27, 2013