BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    ENTERPRISE ELECTROPHYSIOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Fletcher CT/MR Shielded Applicator

    FDA UDI
    Nucletron B.V.·08717213024342·Cervical Stopper (4 mm)

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2024

    LIVESURE COCAINE SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PERIMETER C SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAGELLAN HYPODERMIC SAFETY NEEDLE 25 G X 5/8 INCHES

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code FMI·September 21, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 12, 2026

    NEXGEN STEMMED TIBIAL BASEPLATE

    FDA Adverse Event
    Injury ·ZIMMER·Product code JWH·May 9, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·March 25, 2011

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    PEDIASAT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2024

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

    SAFETY NEEDLE 25 X 5 8

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code FMI·December 28, 2021

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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