BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Sonomed IV, Sonomed V

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 16, 2023

    KSEA NEURO-FIBERSCOPE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PHILIPS HARMONY RELEASE 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWERLINK SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·August 11, 2011

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 16, 2008

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 2, 2013

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    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