BEUDAMED
    20 results · 43ms · Sources: EU EUDAMED, US FDA

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    ZINC PHOSPHATE CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    Premier Excavators

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008425·Excavator DE_OC 17(C22)

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496003427·NAOMI 70, SIZE L, BLU SCURO, GRADUATED COMPRESS...

    GCX M series 12"pivot arm with adapter A

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415904098·

    BD¿ PET SYRINGES VETERINARY INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 29, 2023

    PCA AND AMBULATORY PUMP

    FDA Adverse Event
    Malfunction ·C. R. BARD, INC.·Product code MEA·September 19, 1994

    MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026

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

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·January 17, 2025

    DISTRACTOR TIP FOR MATRIX

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·February 28, 2013

    QUANTUM MAVERICK BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 1, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·February 21, 2008

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 21, 2024

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 21, 2024

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 21, 2024

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 8, 2015

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022