BEUDAMED
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    AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mallinckrodt

    FDA UDI
    Covidien LP·10884521068209·Evac Oral Tracheal Tube,Seal Guard, Murphy Eye

    JOBST SensiFoot

    FDA UDI
    BSN MEDICAL, INC.·00035664108656·SENSIFOOT 8-15 MM HG KNEE HIGH EXTRA SMALL BLAC...

    Shiley

    FDA UDI
    Covidien LP·40884521068200·Evac Oral Tracheal Tube Seal Guard, Murphy Eye

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306803703·Jordan-Simpson Right Angled Retractor 1 1/2"

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642108200·Plate, 26 mm/30 mm (W) x 13 mm (H)

    AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 6, 2024

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 8, 2025

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 9, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    EXPEDIUM UNIVERSAL CONNECTOR 5.6-6.35

    FDA Adverse Event
    Malfunction ·Product code NKB·May 23, 2011

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code DQY·December 25, 2016

    METACROSS RX PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·October 15, 2019

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024