BEUDAMED
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    END-TO-END AND SIDE-BY-SIDE CONNECTORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151064·Endo Carry-on Procedure Kit contains Basin, VIA...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890105630·Zirlux UCLA Plastic Abut N Eng

    Aligned Medical Solutions

    FDA UDI
    Aligned Medical Solutions·B098L0105630·Pediatric Kit - NS

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105030·Implant Inserter, 8-10mm, Sleeveless

    MODIFICATION TO ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    M-SERIES DC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 25, 2012

    REMSTAR AUTO M SERIES

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·April 14, 2024

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 15, 2013

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 1, 2011

    RIATA ST ACTIVE FIXATION LEAD

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

    RUNTHROUGH NS

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018

    RUNTHROUGH NS

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019