BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Visera Elite II Video System Center

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    10PW - MARC - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588096469·10PW - MARC - Poly White

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113493·LAMELLAR BLADE #66-60 (BX/5)

    SPIDER FLEX MONOPOLAR HOOK

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ABX MICROS CRP

    FDA 510(k)
    FDA Class 2 ·Hematology

    UNKNOWN - POLYS

    FDA Adverse Event
    Injury ·DAVIS & GECK CARIBE LTD·Product code GAM·February 17, 2026

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·September 18, 2014

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 24, 2024

    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012