BEUDAMED
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    B-CARE POWDER FREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105640·PowerChem Neoprene Exam Gloves, Large

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210514040·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large

    FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

    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

    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

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·April 10, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·April 7, 2011

    ILLUMENA-SYR-W/HF - 150ML BX50

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DXT·May 16, 2008

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024