BEUDAMED
    141 results · 13ms · Sources: EU EUDAMED, US FDA

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    Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

    FDA Recall
    Open, Classified ·Healthmark Industries Co., Inc.·Product code OCU·March 12, 2026

    Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;

    FDA Recall
    Open, Classified ·Acumed LLC·Product code HRS·December 19, 2023

    1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code GCJ·January 14, 2022

    REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

    FDA Recall
    Open, Classified ·Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden·Product code JOY·October 8, 2025

    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Recall
    Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·December 10, 2018

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Recall
    Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025

    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code OCC·October 10, 2019

    Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code OCY·August 16, 2022

    FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·August 7, 2024

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·April 30, 2025

    NxTAG Respiratory Pathogen Panel, REF: I051C0447

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics Inc·Product code OCC·September 5, 2024

    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics·Product code OCC·July 16, 2019

    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OCC·January 30, 2023

    Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020