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    Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·December 10, 2004

    Wahl 2-Speed All-Body Massager, model 4120-1; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China; Please note: Wahl sells these massagers under other model numbers based on the packaging configuration. All packages contain the model 4120-1 massager, with various attachments. These package models include 4120-200 and 4120-217

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·November 1, 2005

    Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code ISA·June 18, 2008

    WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains.

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·December 15, 2020

    Wahl 2-Speed All-Body Massager with Heat and Discovery Channel brand 8-Way Massager with Heat, model 4196-1; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China; Please note: Wahl sells these massagers under other model numbers based on the packaging configuration. All packages contain the model 4196-1 massager, with various attachments. These package models include 4196-500, 4196-517 and 4196-519

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·November 1, 2005

    Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China." Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface.

    FDA Recall
    Terminated ·King International·Product code ISA·August 30, 2011

    MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP.

    FDA Recall
    Terminated ·MIMvista Corp·Product code LLZ·April 23, 2008

    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.

    FDA Recall
    Terminated ·Acumed LLC·Product code MQV·December 5, 2016

    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·January 18, 2017

    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.

    FDA Recall
    Terminated ·Envoy Medical Corporation·Product code OAF·January 9, 2013

    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.

    FDA Enforcement
    Class II ·Terminated·Envoy Medical Corporation·February 6, 2013

    1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.

    FDA Recall
    Terminated ·American Medical Systems Innovation Center Silicon Valley·Product code GEX·May 28, 2015

    1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.

    FDA Enforcement
    Class II ·Terminated·American Medical Systems Innovation Center - Silicon Valley·July 29, 2015

    SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.

    FDA Recall
    Terminated ·Transenterix, Inc·Product code GCJ·February 25, 2011

    Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Recall
    Terminated ·Hand Biomechanics Lab Inc·Product code JEC·September 14, 2016

    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Enforcement
    Class II ·Terminated·Hand Biomechanics Lab Inc·October 26, 2016

    SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.

    FDA Recall
    Terminated ·Transenterix, Inc·Product code GCJ·February 25, 2011

    The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012

    The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·December 19, 2012

    Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Sterilization occurs via EtO in Germany.

    FDA Recall
    Terminated ·Vygon Corporation·Product code DQO·April 9, 2003