BEUDAMED
    79 results · 59ms · Sources: EU EUDAMED, US FDA

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    Specialty Manufacturing, Inc.

    FDA registration
    Specialty Manufacturing, Inc.·1 product·🇺🇸 United States

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH·Product code NEW·August 29, 2012

    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

    FDA Enforcement
    Class II ·Ongoing·Custom Medical Specialties, Inc.·March 1, 2017

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES PUERTO RICO INC.·Product code NEW·January 28, 2015

    POWERED WHEELCHAIR SYSTEM

    FDA Adverse Event
    Malfunction ·MOTION CONCEPTS LP·Product code ITI·March 2, 2022

    AMS, INC. (INCLUDED IN CUSTOMED KIT)

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SPECIALTIES, INC.·Product code GFA·February 13, 2007

    Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.

    FDA Recall
    Terminated ·Spinal Specialties, Inc·Product code CAZ·April 15, 2005

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES PUERTO RICO INC.·Product code NEW·January 14, 2015

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code POE·December 6, 2024

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH PR INC.·Product code NEW·August 14, 2014

    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

    FDA Recall
    Open, Classified ·Custom Medical Specialties, Inc.·Product code FCH·September 20, 2016

    HENRY SCHEIN

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORPORATION·Product code GAB·October 25, 2017

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES PUERTO RICO INC.·Product code NEW·December 19, 2014

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES PUERTO RICO INC. .·Product code NEW·December 29, 2015

    SENSAR

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·April 2, 2018

    ALP 501

    FDA Adverse Event
    Injury ·CURRIE MEDICAL SPECIALTIES·Product code JOW·September 1, 2012

    BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.

    FDA Enforcement
    Class II ·Terminated·BioDerm, Inc.·June 18, 2014

    BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.

    FDA Enforcement
    Class II ·Terminated·BioDerm, Inc.·June 18, 2014

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES PUERTO RICO INC.·Product code NEW·December 19, 2014

    STRATFIX

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORPORATION·Product code GAB·October 11, 2017