BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    PASSAGE AIRWAY SPLINT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    FLEXI-STOME Nipple Colostomy Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112021051·Nipple Colostomy Tip

    Surgimedics®

    FDA UDI
    COASTAL LIFE TECHNOLOGIES, INC.·00814716020081·Smoke Evacuation Filter

    HOOK SCISSORS INSERT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929013070·HOOK SCISSORS SINGLE-ACTION JAW

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746109751·DB BKT MINI MS UR BIC 018 T-7 A=0 R2D

    Hook Scissors

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896120181·Hook Scissors Single Action Jaws

    ORTHOPANTOMOGRAPH™ OP 3D

    FDA UDI
    PaloDEx Group Oy·06430035875184·ORTHOPANTOMOGRAPH™ OP 3D EX (PAN CEPH 3D)

    CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·January 2, 2013

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 17, 2010

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2021

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021