BEUDAMED
    11 results · 19ms · 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 ×

    SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20237431·Steel arches Straight-Arch-F. max. .017"x.025"

    PADPRO, MODEL 2502

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFERIOR END PLATE MEDIUM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·March 27, 2013

    ENDOPOUCH SPEC BAG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 18, 2011

    1.1 DISPOSABLE GOMCO

    FDA Adverse Event
    Other ·TYCO HEALTHCARE/KENDALL·Product code FHG·March 26, 2008

    Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower limb prosthesis.

    FDA Recall
    Terminated ·Ossur Engineering, Inc·Product code ISP·June 23, 2009

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018