BEUDAMED
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    MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bur PM2-70 80K Carb Ø5.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055503678·

    SimplyGo

    FDA UDI
    Respironics, Inc.·00606959028814·SimplyGo, France

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694089326·ISO Chin Plate, 12mm

    WizardBio Resorbable Calcium Phosphate Cement

    FDA UDI
    DSM BIOMEDICAL, INC.·M263W23000·WizardBio Resorbable Calcium Phosphate Cement

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869684804·MOSS Connectors Holding Forceps, angled, medium

    COROENT XLR STANDALONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VERSA-DIAL 46X24X47 HUM HEAD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·April 24, 2013

    CAPSURE EPI

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code NVN·May 8, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·May 13, 2011

    TRIFURCATED POSIFLOW EXTENSION SET

    FDA Adverse Event
    Malfunction ·MPS ACACIA·Product code FPA·July 25, 2008

    Microdot Xtra blood glucose test strips

    FDA Enforcement
    Class II ·Ongoing·Cambridge Sensors Limited·August 28, 2019

    PC HYBRID GLENOID POST- POLY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·February 28, 2013

    SM HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·February 28, 2013

    ADVIA CENTAUR XPT HEPATITIS B SURFACE ANTIGEN II (HBSII)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·May 14, 2021

    Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325

    FDA Recall
    Terminated ·Mitek Worldwide·June 16, 2003

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 23, 2025

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020