BEUDAMED
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    ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Neodent

    FDA UDI
    JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878047186·NGS NARROW TAPERED DRILL

    STORASCOPE

    FDA UDI
    CANTEL MEDICAL (ITALY) SRL·18011517135481·STORASCOPE Cart with 10 standard trays and lids...

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304198319·

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304229617·

    RINGLOC UNIVERSAL HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304219564·

    SELF CENTERING

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295003380·SELF CENTERING BI-POLAR HEAD 28mm ID 48mm OD

    STANDARD IMAGING IVB 1000 WELL CHAMBER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    FETAL MONITOR/CARDIOTOCOGRAM

    FDA Adverse Event
    Injury ·BISTOS CO., LTD.·Product code HGL·January 29, 2018

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 26, 2011

    28MM COCR MOD HD +6MM NO SKIRT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·November 12, 2020

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·May 5, 2016

    E-POLY 32MM +3 HIWALL LNR SZ22

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MAY·August 19, 2016

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021