BEUDAMED
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    SYNGO NEURO DSA CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00530241·

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809845099·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE LARGE FU...

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005175·SST TWIST DRILL, JACOBS, 2.5mm DIA. X 60mm

    TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02

    FDA 510(k)
    FDA Class 2 ·Radiology

    SELECTIVA GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 5, 2025

    ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

    DISC HUM 4X150MM RT FLANGED C

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDC·April 11, 2013

    NONE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JDI·May 27, 2008

    VIRTUOSO DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·April 13, 2011

    REF H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014