BEUDAMED
    177 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    VITROS 5600 Integrated System (New and Refurbished)

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024

    VITROS 3600 Immunodiagnostic System (New and Refurbished)

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024

    Class IV New Era medical laser device

    FDA Enforcement
    Class II ·Ongoing·Inova Lasers LLC·November 25, 2020

    SMV DSX New Line, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·September 7, 2022

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 29, 2022

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 21, 2023

    Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 3, 2024

    Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 3, 2024

    Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025

    Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·June 14, 2023

    Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

    FDA Enforcement
    Class II ·Ongoing·Covidien·January 10, 2024

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025

    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025