BEUDAMED
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    RANDOX PHENOBARBITAL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMPACT-PLUS

    FDA UDI
    Denplus Inc·D8451011303·IMPACT-PLUS, RPI, 11.3 kg

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890113030·Zirlux Titanium Blank Abutment compatible with:...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810113030·Acrylic Repair Powder

    Ovation Tribute Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409011247·EXT SIZE 3 Stem Plasma Spray

    MASEL

    FDA UDI
    Ortho Organizers, Inc.·00190707053772·GeoShapes™ Elastics 1/4" (6.35 mm) Medium 3.5oz...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450150429·

    DUALCAP

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code LKB·May 12, 2025

    ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BREAST IMMOBILIZATION DEVICE MR-BY 160

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 5, 2025

    UNKNOWN HIP COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 19, 2013

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 11, 2008

    BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 3, 2021

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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