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

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    THE OSTEOREPORT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837040970·Solstice Smooth Shaft Assembly, 4.0 x 40mm long

    ZAVATION

    FDA UDI
    Zavation LLC·00842166190962·Polyaxial Reduction Screw 4.0x40

    BTL-9000; BTL-9000 RADIOFREQUENCY MODULE

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

    ESPRIT VENTILATOR, MODEL V1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CHAMBER COMPLETE AUTOFEED 900

    FDA Adverse Event
    Malfunction ·Product code BTT·May 5, 2021

    CHAMBER COMPLETE AUTOFEED 900

    FDA Adverse Event
    Malfunction ·Product code BTT·January 21, 2020

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 30, 2013

    ENDOPATH** XCEL*

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·December 21, 2010

    SIPS DUAL 2 MINUTE TIP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code FQH·July 15, 2014

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 17, 2023

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 20, 2023

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 23, 2024

    CHAMBER COMPLETE AUTOFEED 900

    FDA Adverse Event
    Malfunction ·Product code BTT·June 3, 2021

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 15, 2024

    CHAMBER COMPLETE AUTOFEED 900

    FDA Adverse Event
    Malfunction ·Product code BTT·February 4, 2021

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53 g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54 h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55 i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51 j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51 k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52 l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52 m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53 n. NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS, REF 136-36-54 o. NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS, REF 136-36-55 p. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP, REF 138-32-51 q. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP, REF 138-32-53 r. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP, REF 138-36-52 s. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP, REF 138-36-53 t. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP, REF 138-36-54 u. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 5 CUP, REF 138-36-55 v. NOVATION GXL LINER, 10 DEG FACE, REPLACED BY 138-36-52, REF 138-32-52 w. NOVATION GXL LINER, LIPPED 32MM ID GROUP 2 CUPS, REF 132-32-52 x. NOVATION GXL LINER, LIPPED ANT, 32MM ID, GROUP 1 CUPS, REF 132-32-61 y. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 2 CUPS, REF 132-36-62 z. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 3 CUPS, REF 132-36-63 aa. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 4 CUPS, REF 132-36-64 bb. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 3 CUPS, REF 132-36-53 cc. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 1 CUPS, REF 132-28-51 dd. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 2 CUPS, REF 132-28-52 ee. NOVATION GXL LINER, LIPPED, 32MM ID GROUP 4 CUPS, REF 132-32-54 ff. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 3 CUPS, REF 132-32-53 gg. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 5 CUPS, REF 132-32-55 hh. NOVATION GXL LINER, LIPPED, 36MM ID GROUP 4 CUPS, REF 132-36-54 ii. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 5 CUPS, REF 132-36-55 jj. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 2 CUPS, REF 130-28-52 kk. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 3 CUPS, REF 130-32-53 ll. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 4 CUPS, REF 130-32-54 mm. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 5 CUPS, REF 130-32-55

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