BEUDAMED
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    FREERIDER MODEL LUGGIE MODEL 168-4IT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780025245·Integra® Jarit® Knife Handle, # 3, 4-7/8", Hold...

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486002596·UNIVERSAL HEX DRIVER 30 mm TIP

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK110151·DD tempMED are pre-colored dental milling blank...

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642108798·Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 13...

    ERO SCAN OAE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PRO-TOE VO HAMMERTOW IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRILOGY100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·November 30, 2023

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·October 22, 2018

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·August 25, 2023

    ARTHREX®

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRX·May 13, 2019

    ARTHREX®

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRX·May 13, 2019

    ARTHREX®

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRX·May 13, 2019

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    FREESTYLE LIBRE 14 DAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code PZE·May 28, 2026

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITJ·May 13, 2013

    PRISM HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code KSJ·September 23, 2014

    LATERALIZED MALLORY/HEAD PF FEMORAL 12 X 165MM STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·June 1, 2011

    PEDIASAT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025