BEUDAMED
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    SIIS#1 TISSUE SUSPENSION SYSTEM

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

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481122866·LOCATOR R-Tx Attachment System, 5.0mm Platform ...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540602559·Bone Screws, MP, Cross-Pin

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221231369·Unitek Miniature Twin MBT UL Cus 0T/8A DHk 022 MMT

    Single Use Biliary Stent V

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170186035·Single Use Biliary Stent V

    RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·December 30, 2015

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 1, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 1, 2011

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 15, 2013

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022

    VENTED MICRO VOL.INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 26, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 16, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008