BEUDAMED
    20 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 ×

    AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925014145·FLPL .6MM PISTON .236"

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003605·Long 4 Hole BSSO Plate

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776160388·McKesson Aspirator Tip Tube Diameter 3.0mm OL18...

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD471400820·7" McKesson Type Suction Tube, 4mm

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036031831·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694031066·Long 4 Hole BSSO Plate, Sterile

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064378·2.0 System 4 Hole Long BSSO Plate Sterile Qty 5

    PORE-SI BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENPRIME DRUGS OF ABUSE READER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HAHN TAPERED IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 25, 2024

    IMP,TSV,4.1MM,DUAL SEL,HA

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code CBK·May 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 25, 2011

    TROJAN BRAND LUBRICATED CONDOM, HER PLEASURE

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·August 28, 2008

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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