BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANATOMIC PEEK PTC Cervical Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169357600·CAGE 5030064 ANATOMIC PTC 16X14X10MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776297435·Right Angle Mosquito Hemostat Forceps 4 1/2"

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037311431·GLENOID RESURFACING REAMER Ø24mm/AO

    Discectomy Set

    FDA UDI
    SPINEOLOGY INC.·M7403030064·Fine Nerve Hook 11.5"/295 MM

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036023560·

    Trinity Biotech

    FDA UDI
    PRIMUS CORPORATION·05391516748605·Hemoglobin A1c assay, PDQ1 Reagent - 940mL

    COPPERHEAD CERVICAL INTERBODY CAGE

    FDA Adverse Event
    Injury ·EMINENT SPINE·Product code ODP·January 8, 2016

    4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190

    FDA 510(k)
    FDA Class 2 ·Hematology

    TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

    FDA 510(k)
    FDA Class 2 ·Immunology

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    2.4/2.7MM TI VA-LCKNG OPENING WEDGE PLATE/7MM SPACER

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HRS·April 2, 2013

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 25, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·April 15, 2008

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021