BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier Excavators

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008449·Excavator DE_OC 24

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099815·MX 1-2 BI BD KT N/L UNIV 131

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWE·May 20, 2022

    MINIMED SILHOUETTE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·December 20, 2024

    SELECT SEED I-125

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO ACCUDEXA BONE DENSITOMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MINIMED SILHOUETTE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·April 28, 2025

    NORIAN SRS BONE VOID FILLER ROTARY MIX 10CC-STERILE

    FDA Adverse Event
    Malfunction ·NORIAN·Product code MQV·February 28, 2013

    VORTX 18 FIBERED PLATINUM COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·March 1, 2011

    BRAVO

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

    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

    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

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018