BEUDAMED
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    GOODE T-TUBE, BIOLITE COATED SILICONE/TU

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MGB Alert® BKV ASR v3.0 Probe Mix

    FDA UDI
    Elitechgroup Mdx LLC·03661540952357·MGB Alert® BK Virus ASR v3.0 Probe Mix contains...

    DSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns

    FDA UDI
    Elitechgroup Mdx LLC·03661540952753·DSQ Alert® BK Virus ASR v3.0 Probe Mix contains...

    DiamondTemp Generator Adapter

    FDA UDI
    ACUTUS MEDICAL, INC.·00850027837253·AcQMap to DiamondTemp Generator Adapter

    ACUMED

    FDA UDI
    Acumed LLC·10806378044304·2.3mm Screw Sleeve, Locking Tab

    BUFFLIGHT CLT SURGICAL LASER SYSTEM

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

    LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AUVON TENS & EMS DEVICE

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    AUVON TENS UNIT

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Recall
    Terminated ·Abbott·Product code MXC·November 19, 2018

    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·September 18, 2025

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code BRY·January 15, 2016

    Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PMP·May 16, 2024

    Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024