BEUDAMED
    56 results · 48ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips.

    FDA Recall
    Open, Classified ·Solta Medical Inc·Product code GEI·February 16, 2023

    Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

    FDA Recall
    Terminated ·Solta Medical, Inc.·Product code ONG·December 15, 2010

    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

    FDA Recall
    Terminated ·Solta Medical, Inc.·Product code ONG·March 20, 2014

    Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    FDA Recall
    Terminated ·Solta Medical Inc·Product code GEI·December 30, 2019

    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    FDA Recall
    Terminated ·Solta Medical Inc·June 1, 2017

    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    FDA Recall
    Terminated ·Solta Medical Inc·June 1, 2017

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387308, .035/180 cm, still/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387319, .038/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387320, .038/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387326, .032/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387302, .035/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323, .038/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387307, .035/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387325, .032/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009