BEUDAMED
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    SureTouch Mobile Pressure Mapping System

    FDA UDI
    SURE INC.·00860000501712·Breast lesion documentation system

    Bexa Pressure Mapping System

    FDA UDI
    SURE INC.·00860000501729·Breast lesion documentation system

    SURE-TECH DIAGNOSTIC ASSOCIATES, INC.

    FDA registration
    SURE-TECH DIAGNOSTIC ASSOCIATES, INC.·2 products·🇺🇸 United States

    KINEDYNE

    FDA Adverse Event
    Other ·SURE-LOK, INC.·Product code IQB·June 20, 2002

    Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    DERMABOND PRINEO 22CM MSH ADHESIVE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OMD·October 3, 2025

    MEDTRONIC, INC. PACEMAKER AZURE XT DR MRI SURE SCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWP·June 8, 2021

    LEEP SYSTEM 1000 ESU GEN.

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code HGI·April 28, 2016

    SEQUENTIAL H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM)

    FDA Adverse Event
    Malfunction ·O&M HALYARD, INC.·Product code FRG·October 10, 2018

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·October 25, 2013

    B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).

    FDA Recall
    Terminated ·Harmony Brands Llc·Product code LCX·March 25, 2005

    LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·September 29, 2006

    ON-Q PAIN RELIEF SYSTEM WITH SAF, 400 ML, 2-14 ML/HR

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code MEB·April 14, 2026

    LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·September 29, 2006

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·August 13, 2025

    HELIOS U46

    FDA Adverse Event
    Malfunction ·CAIRE INC.·Product code BYJ·April 23, 2020

    DERMABOND ADVANCED 0.7ML - 12EA

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code MPN·October 10, 2025

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 20, 2025

    Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.

    FDA Recall
    Terminated ·Stat Medical Devices, Inc.·Product code FMI·May 29, 2009

    ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM)

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSO·April 19, 2022