BEUDAMED
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    ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58211013050·SCISSORS, SURGICAL TISSUE, DENTAL

    Preci-Sagix

    FDA UDI
    Preat Corporation·00842092108642·Sagix 1.7 Complete Plastic w/Housing Includes: ...

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517635518·CoRoent Ant TLIF PEEK, 10x11x30mm 15°

    MULTI-GUIDE

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540133946·BLADE FOR THREAD. PINS AND CLAMP. SCREWS

    CIV-Flex™ Transducer Cover

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103111·Sterile (7.4 tapered to 9.5 x 30.5cm) telescopi...

    ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 1, 2024

    STELLARIS VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

    UNKNOWN POLY BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·May 9, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    SELOX ST 53

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·August 5, 2008

    UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·April 23, 2026

    UNK - BIOMATERIAL - CEMENT: TRAUMACEM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NDN·April 23, 2026

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 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 Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    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