BEUDAMED
    809 results · 12ms · Sources: EU EUDAMED, US FDA

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    PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1

    FDA Recall
    Terminated ·Whirlpool Corporation World Headquarters Benton·Product code NZJ·July 2, 2020

    Thermoplastic templates, single tooth Catalog Number: 040.526

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code DZJ·January 30, 2006

    Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·August 5, 2005

    Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·August 5, 2005

    Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    Thermoplastic templates, free-end situation Catalog Number: 040.527

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code DZJ·January 30, 2006

    Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    FDA Recall
    Terminated ·Avazzia, Inc·Product code GZJ·June 29, 2007

    IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 2, 2013

    Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    FDA Recall
    Terminated ·Avazzia, Inc·Product code GZJ·June 29, 2007

    IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. Alcohol wipe is provided as a cleaning convenience for device electrodes.

    FDA Recall
    Terminated ·Neuro Resource Group Inc·Product code GZJ·February 7, 2011

    Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. Transcutaneous nerve stimulation for pain relief and other medical treatment uses.

    FDA Recall
    Terminated ·Synaptic Corp·Product code GZJ·July 18, 2008

    Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    FDA Recall
    Terminated ·Avazzia, Inc·Product code GZJ·June 29, 2007

    Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    FDA Recall
    Terminated ·Avazzia, Inc·Product code GZJ·June 29, 2007

    Line Powered RePak, Model Number 1785S

    FDA Recall
    Terminated ·Product code GZJ·May 23, 2003

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Enforcement
    Class III ·Terminated·GSK Consumer Healthcare·July 20, 2016

    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·July 18, 2012