BEUDAMED
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    BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oticon

    FDA UDI
    Oticon A/S·05707131256690·NERA PRO, RITE 312 WL STG

    Precise

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657007948·Precise Fine Dissector, 5mm, 45cm,

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G2231317450·Lucae Dress Forceps Delicate, Serrated Tip, Tip...

    Precise

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657075428·Precise Fine Dissector, 5mm, 45cm Insert

    Precise

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657007955·Fine Dissector with Ratchet, 5mm, 45cm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694046268·PrimaLIF LLIF PEEK Implant, 17mm X 22mm X 45mm,...

    Freedom Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215027155·

    BD BBL¿ TRYPTICASE¿ SOY AGAR W 5% SHEEP BLOOD (TSA II) MACCONKEY II AGAR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 4, 2021

    INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 15, 2026

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    GATEWAY PTA DILATION CATHETER

    FDA Adverse Event
    Death ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code GBA·August 21, 2008

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·April 4, 2025

    UNKNOWN WAGNER STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·April 4, 2025

    UNKNOWN WAGNER STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·April 4, 2025

    UNKNOWN WAGNER STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·April 4, 2025

    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