BEUDAMED
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    AlphaVac Multipurpose Mechanical Aspiration (MMA) System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRABRAID

    FDA UDI
    Smith & Nephew, Inc.·03596010547682·ULTRABRAID No.2 COBRAID SUTURE AND ...

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551111061·HALO, 1203-5 VEST PED3, COOLMAX LINER, 1211-1 S...

    AED 21 - 1081 HD Pin Cutter, 19cm in Length

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657069359·A heavy-duty, hand-held manual surgical instrum...

    IQ FLEX M

    FDA Adverse Event
    Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

    ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 31, 2025

    TALEN THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 24, 2008

    SUTURABLE DURAGEN DURAL REGEN MATRIX

    FDA Adverse Event
    Malfunction ·INTEGRA, PLAINSBORO·Product code GXQ·August 5, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    ULTRBRD2 COBRAID 38 SNGL ARM PACK AS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code GAT·January 6, 2021

    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