BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    SPIRO ANALYZER MODEL ST 250

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    18 French Pediatric Flexi Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112021068·18 Fr Pediatric Flexi Tip

    18 French Pediatric Flexi Tip

    FDA UDI
    Bracco Diagnostics Inc.·10815112021204·18 Fr Pediatric Flexi Tip

    MICRO SCISSORS INSERT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929013080·MICRO SCISSORS STRAIGHT SINGLE-ACTION JAW

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746109805·DB BKT MINI MS UL BIC 018 T-7 A=0 R2D

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221111401·3M™ Victory Series™ First Molar Bands Kit, Lowe...

    ORTHOPANTOMOGRAPH™ OP 3D

    FDA UDI
    PaloDEx Group Oy·06430035875191·OP 3D EX CEPH UPGRADE KIT

    TCP SYSTEM

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118851·

    MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS PC UNIT, MODELS 8000 AND 8015

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

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

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

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

    EVITA XL

    FDA Adverse Event
    Injury ·DRAEGER MEDICAL GMBH·Product code CBK·December 14, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019

    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