BEUDAMED
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    7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Synthes GmbH·10886982143303·1.8MM BUTTRESS PIN/16MM

    REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Q LAB SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

    MPACT FLAT PE HC LINER Ø32/D

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·June 23, 2023

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

    IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FAD·September 20, 2024

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD

    FDA Adverse Event
    ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013

    DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties.

    FDA Recall
    Terminated ·Velocity Medical Solutions, LLC·Product code LLZ·July 25, 2013

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    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