BEUDAMED
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    Veolity

    FDA 510(k)
    FDA Class 2 ·Radiology

    Exact Medical Manufacturing, Inc.

    FDA UDI
    EXACT MEDICAL MANUFACTURING, INC.·00852205007717·Drape, Sheet, 2Ply

    K2 OPAQUER powder, O-A1, 15g.

    FDA UDI
    Yeti Dentalprodukte GmbH·EYET3201501·

    Tasso+

    FDA UDI
    Tasso Inc.·00860006434595·

    Lockheed - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal

    16PW - Loggers - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White

    ArtiSential Laparoscopic Instrument-Electrodes

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BOWL 6 L W/O DRAINAGE 201501

    FDA UDI
    Merivaara Oy·06438435015018·Operating table accessory

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 29, 2023

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·June 6, 2023

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 26, 2019

    GENESIS MALLEABLE PENILE IMPLANT

    FDA Adverse Event
    Injury ·COLOPLAST MANUFACTURING US LLC·Product code FAE·October 17, 2008

    EON MINI RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 3, 2011

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 26, 2013

    SURGUARD3 SAFETY

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code MEG·March 9, 2016

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 3, 2023

    Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·December 18, 2013

    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

    FDA Enforcement
    Class I ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014

    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 10, 2014