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

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    MAC 800 RESTING ECG ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743656·ACHIMED ACHILLES SUPP SILVER II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743489·LEVAMED ANKLE SUPPORT SILVER II

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481476897·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027834·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023956·PADDLE SPREADER, 12MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102120·Shaver, Open 12mm

    NGB-001 Needle-guided Bracket

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904001562·

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 28, 2024

    OFFSET TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KSEA CHARDONNES MORCELLATION KNIFE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 13, 2019

    LANX SPINOUS PROCESS FUSION PLATE

    FDA Adverse Event
    Injury ·LANX, INC.·Product code KWP·March 17, 2011

    FORTIFY ASSURA DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 15, 2014

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·April 11, 2011

    An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024