BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE

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

    Paralleling Pin 2mm/3mm

    FDA UDI
    STERNGOLD DENTAL LLC·00841549118074·Paralleling Pins can be placed into the osteoto...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111066092·

    NEEDLE-SHIELD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    FDA Adverse Event
    Malfunction ·ZYNO MEDICAL, LLC·Product code FRN·October 8, 2020

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CGA·November 22, 2010

    TENDRIL DX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    TO GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021

    GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021

    GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FPA·October 29, 2025