BEUDAMED
    44 results · 42ms · 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.

    THL1 LASER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Oticon A/S·05707131155955·AGIL PRO, RITE DBL DEMO L

    EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471155691·V Nat D 020 Up

    BONASTENT® Tracheal/Bronchial

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369468169·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450197059·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450412770·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450197134·

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001256·Inset 1 Level ACP, 9mm

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361000105·Arena-L, Lordotic 10 degrees, 35X26X09

    HARDYDISK, VANCOMYCIN 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CEDARS-SINAI BPGS AND MOCO

    FDA 510(k)
    FDA Class 2 ·Radiology

    STELO GLUCOSE BIOSENSOR SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code SAF·April 28, 2025

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2013

    STYLE 468 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·May 16, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·August 6, 2008

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·February 12, 2024

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 14, 2024

    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 5, 2015

    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012