BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    EXTEMP/EXTEMP-V

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Preat

    FDA UDI
    Preat Corporation·00842092155738·Screw Extractor Kit Internal Hex Zimmer TSV 3.5...

    ALIGNER PLIERS

    FDA UDI
    Ortho Arch Company Inc·D90980015314·ALIGNER PLIERS - VERTICAL PUNCH

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306809637·Female Luer Lock Cap

    SMR ECC.ADAPTOR TAPER STANDARD

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code KWT·October 24, 2019

    ARTHRO-SURGIMAT-A103

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NQO·March 17, 2022

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 8, 2014

    ION¿

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·October 22, 2012

    ECHELON 45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2010

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021