BEUDAMED
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    BUHLMANN fCAL ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Cohere

    FDA UDI
    Nuvasive, Inc.·00195377028105·COHERE TLIF-O Trial, 18x10mm 12°

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813019061·GLOVES LTX PF ALOE&VIT E LRG DARBY

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193110684·HA PEEK EVOS Rotate, , 12mmx11mmx 30mm , FLAT 8...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197499408·Burford Valves, paired 64x80m...

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071150655·18F x 1.0cm MiniSPC Low Profile Suprapubic Cath...

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071148034·18F x 1.0cm MiniSPC Low Profile Suprapubic Cath...

    V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACCELERATOR A3600

    FDA Adverse Event
    Malfunction ·INPECO SA·Product code JQP·December 20, 2024

    Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·January 22, 2014

    Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HTE·September 24, 2013

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    EMG TECHNOLOGY CO. LTD·Product code BTI·June 20, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·September 29, 2008

    CHROMID® CARBA SMART

    FDA Adverse Event
    Malfunction ·BIOMERIEUX S.A.·Product code JSO·August 23, 2018

    EXPRESSEW III AC+ GUN

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code LXH·November 12, 2020

    EXPRESSEW III AUTOCAPTURE + SUTURE PASSER

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code LXH·February 23, 2023

    Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·January 22, 2014

    Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·January 22, 2014