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

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

    TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025

    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001

    FDA Enforcement
    Class II ·Ongoing·Stryker Medical Division of Stryker Corporation·March 22, 2023

    FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.

    FDA Enforcement
    Class II ·Ongoing·Ferno-Washington Inc·October 22, 2025

    Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

    FDA Enforcement
    Class II ·Ongoing·Stryker Medical Division of Stryker Corporation·December 21, 2022

    FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).

    FDA Enforcement
    Class II ·Ongoing·Ferno-Washington Inc·November 16, 2022

    Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507

    FDA Enforcement
    Class II ·Ongoing·Stryker Medical Division of Stryker Corporation·July 19, 2023

    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

    FDA Enforcement
    Class II ·Ongoing·Hamilton Co·March 10, 2021

    Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.

    FDA Enforcement
    Class II ·Ongoing·Biomet, Inc.·May 1, 2024