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

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    EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022

    VENTED MICRO VOL.INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022

    250 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

    EXACTA-MIX 2400 COMPOUNDING SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code NEP·February 27, 2023

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040099612·Gutta Percha Points Cadm Free

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00270651·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040140526·Gutta Percha Points Cadm Free

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810027051·Gutta Percha Points Cadm Free

    Synergy Disc Instruments

    FDA UDI
    Synergy Spine Solutions Inc·M67091000027050·Implant Adapter, 5mm

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 13, 2013

    UNKNOWN DEPUY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 17, 2011

    MICROSTAAR INJECTOR CARTRIDGE

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code KYB·February 26, 2008

    Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch

    FDA Recall
    Terminated ·Bioteque America Inc·February 24, 2005

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013