BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Hegar Dilator

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030836·Hegar Dilator 11-12mm

    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

    FDA UDI
    TENON MEDICAL, INC.·B74240308360·7.5mm Funnel Flange

    BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES SYNEX SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTE-STACK K030736, K041197

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

    TERUMO STERNAL SAW II

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·March 28, 2013

    ICEMAN THERAPY UNIT

    FDA Adverse Event
    Injury ·DJ ORTHOPEDICS DE MEXICO·Product code ILO·March 21, 2011

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Other ·EDWARDS LIFESCIENCES·Product code KRH·April 17, 2008

    TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·September 9, 2015

    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    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