BEUDAMED
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    Heel Incision Safety Lancet

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777471·LUMBAMED PLUS FLEX PAD WM SILVER V

    SOFTSILK

    FDA UDI
    Smith & Nephew, Inc.·00885554011111·MTO SOFTSILK SCREW 13MMX25MM STRL ...

    EMS 3000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HELICOBACTER PYLORI ELISA IGG TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    BD SAFETYGLIDE SYRINGE W/NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 25, 2020

    STERRAD NX STERILIZER

    FDA Adverse Event
    Injury ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·October 23, 2008

    HIP 2.3 CURVED SYSTEM

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ASDD MANSFIELD MANUFACTURING SITE·Product code NBH·August 12, 2011

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025