BEUDAMED
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    FASTPACK CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044957·Plugger Dr Luks

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450397374·

    RIVA Posterior Fixation System

    FDA UDI
    XENIX MEDICAL LLC·00840493414225·Pedicle Tap, 9.5mm

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00840967161730·NARROW BLADE THORACIC INFRALAMINAR REDUCTION HO...

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00840967169743·NARROW BLADE THORACIC INFRALAMINAR HOOK, 9.5mm

    TRIALTIS

    FDA UDI
    Medos International Sàrl·10705034592107·TRIALTIS Spine System Tap,Short 9.5mm 3-12cm ± 1%

    EINSTEIN PROCESSING AND REVIEW WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    OLYMPUS SONOSURG TROCAR XT3900 SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    MATRIX 1.4MM DRILL BIT/J-LATCHCALIBRATED FOR 03.511.009

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HTW·March 13, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 28, 2011

    IMPLANTIUM

    FDA Adverse Event
    Other ·DENTIUM CO., LTD.·Product code DZE·February 22, 2008

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024