BEUDAMED
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    ESTEMP IMPLANT, ESTEMP CLEAR

    FDA 510(k)
    FDA Class 2 ·Dental

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00844856067509·4.0mm Variable Angle, Self-Tapping Hexalobe Scr...

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G2231340210·Operating Scissors 5 1/2"

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376329802·4.0mm Fixed Angle, Self-Tapping Screw, Single L...

    MP Reconstruction System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575080168·Instrument tray - General instrument

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545981·SPS FA Self-Tap Screw, 4.0 x 21 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376695136·PROXIMITY FA SELF-TAP SCREW, 4.0 x 21mm

    ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VACUUM ASSISTED CORE BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UNKNOWN DEPUY BONE CEMENT

    FDA Adverse Event
    Injury ·9610921 DEPUY CMW·Product code LOD·May 29, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 20, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015