BEUDAMED
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    Leg and Foot Air Wave Pressure Therapy Device

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CALLISTO EYE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 17, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013

    PHILIPS ZOOM

    FDA Adverse Event
    Injury ·DISCUS DENTAL, LLC·Product code EEG·July 16, 2020

    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 FA-71350-25V16 FA-71400-25V10 FA-71425-35V13 FA-71475-30V16 FA-71300-25V12 FA-71350-25V17 FA-71400-25V11 FA-71425-35V15 FA-71475-30V18 FA-71300-25V13 FA-71350-25V18 FA-71400-25V12 FA-71425-35V18 FA-71475-35V09 FA-71300-25V15 FA-71350-25V19 FA-71400-25V13 FA-71450-25V09 FA-71475-35V10 FA-71300-25V16 FA-71350-30V09 FA-71400-25V15 FA-71450-25V10 FA-71475-35V11 FA-71300-25V17 FA-71350-30V10 FA-71400-25V16 FA-71450-25V11 FA-71475-35V12 FA-71300-25V18 FA-71350-30V12 FA-71400-25V18 FA-71450-25V12 FA-71475-35V13 FA-71300-25V19 FA-71350-30V13 FA-71400-25V19 FA-71450-25V13 FA-71475-35V15 FA-71300-30V09 FA-71350-30V15 FA-71400-30V09 FA-71450-25V15 FA-71475-35V18 FA-71300-30V12 FA-71350-30V16 FA-71400-30V10 FA-71450-25V16 FA-71475-35V19 FA-71300-30V13 FA-71350-30V18 FA-71400-30V11 FA-71450-25V18 FA-71500-25V09 FA-71300-30V15 FA-71350-35V09 FA-71400-30V12 FA-71450-25V19 FA-71500-25V10 FA-71300-30V16 FA-71350-35V10 FA-71400-30V13 FA-71450-30V09 FA-71500-25V11 FA-71300-30V19 FA-71350-35V12 FA-71400-30V15 FA-71450-30V10 FA-71500-25V12 FA-71300-35V09 FA-71350-35V13 FA-71400-30V16 FA-71450-30V11 FA-71500-25V13 FA-71300-35V12 FA-71350-35V15 FA-71400-30V18 FA-71450-30V12 FA-71500-25V15 FA-71300-35V13 FA-71350-35V18 FA-71400-35V09 FA-71450-30V13 FA-71500-25V16 FA-71300-35V15 FA-71375-25V09 FA-71400-35V13 FA-71450-30V15 FA-71500-25V18 FA-71325-25V09 FA-71375-25V10 FA-71400-35V15 FA-71450-30V16 FA-71500-25V19 FA-71325-25V10 FA-71375-25V11 FA-71400-35V18 FA-71450-30V18 FA-71500-30V09 FA-71325-25V12 FA-71375-25V12 FA-71425-25V09 FA-71450-30V19 FA-71500-30V10 FA-71325-25V13 FA-71375-25V13 FA-71425-25V10 FA-71450-35V09 FA-71500-30V11 FA-71325-25V15 FA-71375-25V15 FA-71425-25V11 FA-71450-35V10 FA-71500-30V12 FA-71325-25V18 FA-71375-25V16 FA-71425-25V12 FA-71450-35V12 FA-71500-30V13 FA-71325-25V19 FA-71375-25V17 FA-71425-25V13 FA-71450-35V13 FA-71500-30V15 FA-71325-30V09 FA-71375-25V18 FA-71425-25V15 FA-71450-35V15 FA-71500-30V16 FA-71325-30V10 FA-71375-25V19 FA-71425-25V16 FA-71450-35V16 FA-71500-30V17 FA-71325-30V12 FA-71375-30V09 FA-71425-25V18 FA-71475-25V09 FA-71500-30V18 FA-71325-30V13 FA-71375-30V10 FA-71425-25V19 FA-71475-25V10 FA-71500-35V09 FA-71325-30V15 FA-71375-30V12 FA-71425-30V09 FA-71475-25V11 FA-71500-35V10 FA-71325-30V16 FA-71375-30V13 FA-71425-30V10 FA-71475-25V12 FA-71500-35V11 FA-71325-30V18 FA-71375-30V15 FA-71425-30V11 FA-71475-25V13 FA-71500-35V12 FA-71325-30V19 FA-71375-30V16 FA-71425-30V12 FA-71475-25V15 FA-71500-35V13 FA-71325-35V09 FA-71375-30V18 FA-71425-30V13 FA-71475-25V16 FA-71500-35V15 FA-71325-35V12 FA-71325-35V13 FA-71325-35V15 FA-71350-25V09 FA-71350-25V10 FA-71350-25V13 FA-71350-25V15 FA-77250-10V13 FA-77250-10V19 FA-77250-12V11 FA-77250-12V12 FA-77250-12V13 FA-77250-12V18 FA-77250-14V12 FA-77250-14V13 FA-77250-14V15 FA-77250-14V18 FA-77250-14V19 FA-77250-16V11 FA-77250-16V12 FA-77250-16V13 FA-77250-16V15 FA-77250-16V16 FA-77250-16V19 FA-77250-18V09 FA-77250-18V10 FA-77250-18V11 FA-77250-18V12 FA-77250-18V13 FA-77250-18V16 FA-77250-18V18 FA-77250-18V19 FA-77250-20V10 FA-77250-20V11 FA-71375-35V09 FA-71375-35V12 FA-71375-35V13 FA-71375-35V15 FA-71375-35V16 FA-71375-35V18 FA-71400-25V09 FA-77275-14V11 FA-77275-14V12 FA-77275-14V13 FA-77275-14V17 FA-77275-14V18 FA-77275-14V19 FA-77275-16V12 FA-77275-16V13 FA-77275-16V16 FA-77275-16V18 FA-77275-16V19 FA-772

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026