BEUDAMED
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    CORIN METAFIX FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORIN METAFIX HIP STEM

    FDA Adverse Event
    Injury ·CORIN MEDICAL·Product code LZO·September 6, 2022

    Elekta Unity

    FDA UDI
    ELEKTA LIMITED·05060191071499·Indexing Bars

    MiniKut

    FDA UDI
    DENTAL ENGINEERING LABORATORIES, LLC·00850001745772·MiniKut Retreatment Endodontic Files 25/.08, 25...

    Centaur Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215126872·

    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235

    FDA 510(k)
    FDA Class 2 ·Hematology

    ASAHI REXEED-LX SERIES DIALYZER

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 29, 2013

    BIVONA CUSTOM 3.5 FLEXTEND TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 28, 2011

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·July 22, 2008

    BMT 360 TIB TRAY 71MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 1, 2018

    BIOMET SMOOTH KNEE STEMS 16X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 1, 2018

    VNGD SSK PS TIB BRG 14X71/75

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 1, 2018

    BMT 360 TIB LG CRUCIATE WING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·June 1, 2018

    BMT 360 TIB 5.0 OFFSET ADAPTER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 1, 2018

    BMT 360 2.5MM OFFSET ADAPTER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 1, 2018

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024