BEUDAMED
    18 results · 22ms · 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 ×

    INFILL CERVICAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENVELOPE STYLE ARM SLING 2XL

    FDA UDI
    Bird & Cronin, LLC·00610570174560·

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925027084·FLUOROPLASTIC PISTON 4.0 MM FUNCTIONAL LENGTH 0...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704523·Kocher Forceps 5-1/2" (13.8cm), straight, 1x2 t...

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450322444·

    SIREMOBILE C06

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    HUT EXT DR FINAL ASSY-STANDARD

    FDA Adverse Event
    Malfunction ·LIEBEL - FLARSHEIM CO.·Product code IXR·May 29, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·August 27, 2008

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code MIH·August 25, 2020

    AERO LL FIXATION ANCHOR, 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code OVD·March 25, 2019

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    FDA Adverse Event
    Death ·WILLIAM COOK EUROPE·Product code MIH·October 5, 2022

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 20, 2015

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013