BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    ALPHASPHERE ORBITAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Premier K-FILES

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053298·FILES PKG 6 31MM 40

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 11, 2022

    MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR

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

    HEMCON BANDAGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 11, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    FMP HIP SYSTEM

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWB·May 28, 2008

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

    SYNCHRO2-14 SUPPORT STRAIGHT 215CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 27, 2011

    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

    FDA Recall
    Terminated ·Theken Spine Llc·Product code NOX·August 26, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012