BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828184731·GEN4 INTERACTIVE

    NexxZr™ / W-98-35-UT-B400-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271139177·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172971185·

    SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 2, 2021

    ORAL/ENTERAL SYRINGES

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

    MODIFICATION TO: QWH-420 WRIST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELEKTA INFINITY

    FDA Adverse Event
    Malfunction ·ELEKTA SOLUTIONS AB·Product code IYE·November 11, 2025

    RELION PRIME BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY, INC.·Product code NBW·May 9, 2013

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 19, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 25, 2011

    BD PLASTIPAK¿ 50 ML LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 19, 2021

    BD SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 19, 2021

    BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 19, 2022

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021