BEUDAMED
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    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories·Product code OYX·February 15, 2024

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EBL·March 18, 2021

    Omnipod 5 Automated Insulin Delivery System

    FDA Recall
    Open, Classified ·Product code QFG·February 28, 2023

    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

    FDA Recall
    Open, Classified ·NuVasive Inc·Product code OLO·July 19, 2022

    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code GCJ·June 7, 2022

    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code GCJ·June 7, 2022

    Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.

    FDA Recall
    Open, Classified ·Stryker Sustainability Solutions·Product code KCY·March 12, 2026

    TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

    FDA Recall
    Open, Classified ·TriMed Inc.·Product code LXH·September 28, 2018

    TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

    FDA Recall
    Open, Classified ·TriMed Inc.·Product code LXH·September 28, 2018

    TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

    FDA Recall
    Open, Classified ·TriMed Inc.·Product code LXH·September 28, 2018

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·October 2, 2024

    TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

    FDA Recall
    Open, Classified ·TriMed Inc.·Product code LXH·September 28, 2018

    TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

    FDA Recall
    Open, Classified ·TriMed Inc.·Product code LXH·September 28, 2018

    Medtronic Reveal LINQ LNQ11 / PA96000

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·June 1, 2021

    X80 RADiant Photoelectric Therapy System

    FDA Recall
    Open, Classified ·Xstrahl Limited·Product code JAD·April 27, 2022

    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

    FDA Recall
    Open, Classified ·Conavi Medical Inc.·Product code OBJ·March 12, 2025

    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·January 3, 2024

    Philips IntelliSpace Cardiovascular software, Model 830089.

    FDA Recall
    Open, Classified ·Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands·Product code LLZ·April 4, 2024