BEUDAMED
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    ACCU02 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Imola-Silverstone

    FDA UDI
    Altus Spine, LLC·00843210133676·Distractor, 07mm

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193103228·HA PEEK EVOS Curved, , 7mmx9mmx 30mm , FLAT 0 d...

    BR Surgical, LLC

    FDA UDI
    BR Surgical, LLC·00840183502010·TEBBETTS Right Angle Retractor with teeth, fibe...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710610280100·Tri-Channel Met-Traverse, 28mm x 10mm

    ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EASYLINK

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JQP·November 25, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    TVL-ADX ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    NDEHP 3CLV YSTE MACR

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·April 4, 2011

    EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018