BEUDAMED
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    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PAM·November 7, 2023

    Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PAM·June 20, 2024

    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

    FDA Recall
    Open, Classified ·Sonendo Inc·Product code ELC·October 14, 2022

    INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·October 7, 2022

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code NJR·March 18, 2022

    LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;

    FDA Recall
    Open, Classified ·Implant Direct Sybron Manufacturing LLC·Product code NHA·May 2, 2023

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code NJR·December 13, 2024

    Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OYB·February 18, 2026

    da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·August 21, 2024

    da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·June 12, 2023

    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·June 4, 2018

    Cirq Arm System 2.0

    FDA Recall
    Open, Classified ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code OLO·March 2, 2023

    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

    FDA Recall
    Open, Classified ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·February 25, 2022

    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

    FDA Recall
    Open, Classified ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·February 14, 2023

    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

    FDA Recall
    Open, Classified ·Brainlab AG Olof-Palme-Str. 9 Munich Germany·Product code LLZ·February 10, 2025

    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code JTW·January 27, 2022

    Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·March 13, 2024

    8MM,CADIERE FORCEPS,IS4000 REF 470049

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·December 19, 2024

    8MM,TENACULUM FORCEPS,IS4000 REF 470207

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·December 19, 2024

    8MM,PROGRASP FORCEPS,IS4000 REF 471093

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·December 19, 2024