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

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    DANA DIABECARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001604·artVeneer life upper anteriors, BIL, BL3

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092133491·Biomet 3i Certain®-compatible 3.4mm Closed-Tray...

    SCANLAN® A/V Punch

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159000870·SCANLAN® A/V Punch, 4.5 mm

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00190376065458·BATTALION, LLIF PRIMARY DISTRACTOR, 1/4" SQ. ST...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188126·Battalion, LLIF Trial, 0°, 16 mm Wide, 04 mm X ...

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00811801033308·Lateral Distractors - 20mm taper, 16 x 4

    Intervertebral Disc Preparation Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00190376380971·LIF, BROACH, CC OFFSET, 16MM X 04MM

    Intervertebral Disc Preparation Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00190376380582·LIF, BROACH, STRAIGHT, 16MM X 04MM

    EPIDURAL CATHETERIZATION SET NRFIT

    FDA Adverse Event
    Malfunction ·Product code CAZ·March 1, 2021

    WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Valence Robotic Navigation System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376646930·BROACH, LIF NAV, STRAIGHT, 16MM X 04MM

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 7, 2013

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code HCG·February 25, 2011

    CAST CUTTER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAB·August 12, 2014

    Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·April 15, 2003

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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