BEUDAMED
    22 results · 24ms · 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 ×

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm

    GUIDANT AXIUS CORONARY SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RINGFIX

    FDA UDI
    Stryker GmbH·00886385010311·Modular Component Tray; Case I (Empty)

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033379110·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033092927·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033092934·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033092941·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0101100·Caddie Lid, Modular Heads, Polyaxial

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm

    COMFORT STIM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INSET 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 2, 2025

    DELTAFILL18 8MM X 35CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·April 28, 2021

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 1, 2011

    ELITE PASS SHUTTLE NEEDLE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HXI·March 10, 2008

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·May 18, 2011

    Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·February 17, 2016

    Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011