BEUDAMED
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    BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)

    FDA 510(k)
    FDA Unclassified ·Unknown

    ALLOFIT ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZYGOMATIC IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·June 27, 2024

    ALLOFT-S ALLOCLASSIC SHL 52/II

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code JDI·March 12, 2019

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·March 27, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·March 18, 2011

    PALINDROME RUBY 23 / 40 KIT VT

    FDA Adverse Event
    Other ·TYCO HEALTHCARE/KENDALL·Product code MPB·March 25, 2008

    ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·September 27, 2018

    NEEDLE NS 25GA 3/4IN W/O SILICONE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 17, 2019

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 12, 2025

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018