BEUDAMED
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    LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019065·Endo Carry-On Procedure Kit

    AirLife™

    FDA UDI
    VYAIRE MEDICAL, INC.·10190752156609·Misty Finity™ Medium Volume High Flow Continuou...

    AirLife™

    FDA UDI
    AIRLIFE·10889483571309·Misty Finity™ Medium Volume High Flow Continuou...

    AirLife

    FDA UDI
    Carefusion Corporation·10885403039287·Airlife™ Misty Finity™ Medium Volum...

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009214·PedFuse, Rod, Straight, Bulleted, 5.5mm X 35mm

    ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUANTA LITE LKM-1 ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·July 2, 2025

    BD HYPOINT¿ HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·May 26, 2023

    TECNIS SYNERGY IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code MFK·September 30, 2024

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 13, 2013

    ALLURA XPER FD20

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·January 28, 2011

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HXX·February 7, 2008

    Medshape Universal Joints, REF: DNE-9000-UJ

    FDA Enforcement
    Class II ·Ongoing·Medshape, INC.·September 10, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024