BEUDAMED
    16 results · 34ms · Sources: EU EUDAMED, US FDA

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    SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDVIZER PACS, MODEL RELEASE 2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    3008261720-2024-002557

    FDA Adverse Event
    Injury ·JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA·Product code DZE·September 2, 2024

    RHK SEGMENTAL SHORT YOKE

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·December 7, 2016

    QUICKSET TPRD HEX SCDR U-JOINT

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·June 26, 2014

    QUICKSET TPRD HEX SCDR U-JOINT

    FDA Adverse Event
    Malfunction ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LXH·June 13, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·January 28, 2011

    INDURA

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·February 8, 2008

    QUICKSET TPRD HEX SCDR U-JOINT

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·March 22, 2014

    QUICKSET TPRD HEX SCDR U-JOINT

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 28, 2014

    Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2557-000-10.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code GCY·January 29, 2008

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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