BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    VITEK 2 GRAM POSITIVE DAPTOMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Conmed/Linvatec

    FDA UDI
    Provision·B504OM50911260·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16710911260·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green

    Conmed/Linvatec

    FDA UDI
    Provision·00810041066206·

    NA

    FDA UDI
    STERILMED, INC.·10888551017954·BUR ROUND MEDIUM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450226254·

    RAICHEM CREATININE URINE STANDARD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HSB·March 3, 2025

    ANESTAR ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC.·Product code MCM·May 9, 2011

    Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.

    FDA Enforcement
    Class II ·Ongoing·Stryker GmbH·June 18, 2025

    AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 24, 2010

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    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