BEUDAMED
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    INTELLISPACE PACS 4.X

    FDA 510(k)
    FDA Class 2 ·Radiology

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930711180400·Ring Curette #4 STR 18" 9" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930711180410·Ring Curette #4 ANG 18" 9" handle

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260857·

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014

    GIRAFFE AND PANDA WARMERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANTX LCV+

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS SCS·Product code IZI·May 7, 2013

    SPECTRA CONCEALABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·May 26, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 10, 2024

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code MRG·June 30, 2004

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025