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

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    INVOTEC BI-VALVE SPLINT

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

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746108518·DB BKT MINI MS UL CUSP 018 T-2 A+10 R4M

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

    PERITONEAL SCISSORS INSERT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929013060·PERITONEAL SCISSORS STRAIGHT SINGLE-ACTION JAW

    FLEXI-STOME Cone Colostomy Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112021655·Cone Colostomy Tip

    FLEXI-STOME Cone Colostomy Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112021044·Cone Colostomy Tip

    FLEXI-STOME Cone Colostomy Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112020641·Cone Colostomy Tip

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221111395·3M™ Victory Series™ First Molar Bands Kit, Lowe...

    AMSURE PVC INTERMITTENT CATHETER

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

    STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ShurFit MALIF System

    FDA UDI
    PRECISION SPINE, INC.·00840019925273·Cup Curette 6mm x 90˚ Up Pulling

    HAMILTON-C3

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 16, 2026

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014

    GREENLIGHT HPS BPH FIBER OPTIC

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

    APEX OVER-THE-WIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·November 17, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

    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