BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450329290·

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122162·KWire .035x4" (0.9x100mm)

    MICASEPT LUNG GRASPING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09920919000040·MICASEPT LUNG GRASPING FORCEPS AND NODE GRASPER...

    MICASEPT LUNG GRASPING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896008021·MICASEPT LUNG GRASPING FORCEPS AND NODE GRASPER...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702357851·Elvarex 2/Knee High/Slant-Closed Toe-Elephantia...

    Cancellous Screws

    FDA UDI
    aap Implantate AG·04042409088520·Washer, I-ø8.6, A-ø19.0 Titanium

    ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    GLUCOSE (HEXOKINASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·April 1, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    ACCUTORR V MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    INTRA-AORTIC BALLOON PUMP

    FDA Adverse Event
    Death ·DATASCOPE CORP.·Product code DSP·August 20, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 18, 2011

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 27, 2020

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015