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

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    STATSEAL DISC

    FDA 510(k)
    FDA Unclassified ·Unknown

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577375·CoRoent Ant TLIF PEEK, 13x10x32mm 4°

    ArgenZ HT+ 98x14 ML C4B

    FDA UDI
    ARGEN CORPORATION, THE·D818130324·Dental porcelain/ceramic restoration kit

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1303240·

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05065025111716·KLEOS 2 PSL METAL STANDARD TORQUE 022 UL45 HK PK5

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450190159·

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613153992462·Posterior Stabilized Tibial Insert

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 8, 2023

    RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 14, 2016

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·May 22, 2013

    WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·June 16, 2011

    ETS FLEX ARTICNG LNR CUTR 45MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 20, 2008

    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

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