BEUDAMED
    23 results · 19ms · Sources: EU EUDAMED, US FDA

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    BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code KZJ·November 23, 2005

    GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code KZJ·August 13, 2010

    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 4, 2018

    Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 4, 2018

    Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

    FDA Recall
    Terminated ·Cook Inc.·Product code MQF·December 19, 2017

    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

    FDA Recall
    Terminated ·Cook Inc.·Product code MQF·December 19, 2017

    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