BEUDAMED
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    LATERAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROCEDURE MASKS: PM4-301 AND PM4-304

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

    SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

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

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 28, 2025

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·January 31, 2025

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    ACCU-CHEK ® FLEXLINK INFUSION SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·April 16, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 30, 2011

    CADIERE FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·June 13, 2008

    PROWLER SELECT

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRA·January 31, 2025

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012