BEUDAMED
    351 results · 15ms · Sources: EU EUDAMED, US FDA

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    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Enforcement
    Class II ·Ongoing·NOA Medical Industries Inc·January 22, 2025

    Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Not Yet Classified ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Lazervida 10W diode laser cutter and engraver with Lazervida shield.

    FDA Enforcement
    Class II ·Ongoing·Flux Technology Inc.·June 11, 2025

    RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

    Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

    DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

    FDA Enforcement
    Class II ·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025

    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

    FDA Enforcement
    Class II ·Ongoing·Quidel Corporation·February 21, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Healthmark Industries Co., Inc.·May 6, 2026

    Lamicel 10PK 10MM INTL

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·January 1, 2020