BEUDAMED
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    HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040009772·Zirlux 16+ 0M3 100X12

    Triad

    FDA UDI
    Nuvasive, Inc.·00887517067883·12mm Paddle Distractor Assy Color Coded

    TT MB BASEPLATE

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code KWT·January 26, 2026

    SMR GLENOID BASEPLATE SMALL-R

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 4, 2020

    INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COPELAND MB RESURFACING HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 19, 2013

    N/A

    FDA Adverse Event
    Malfunction ·ASCENT·Product code NLM·March 9, 2011

    EMBRACE PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·March 10, 2008

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·February 11, 2016

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·July 9, 2024

    SMR GLENOID BASEPLATE SMALL-R

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·August 26, 2021

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024