63 results
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53ms
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Sources: EU EUDAMED, US FDA
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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
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 Enforcement
Class II
·Terminated·Solta Medical Inc·August 30, 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 Enforcement
Class II
·Terminated·Solta Medical Inc·August 30, 2017
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
FDA Enforcement
Class II
·Terminated·Solta Medical, Inc.·April 23, 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 Enforcement
Class II
·Terminated·Solta Medical Inc·April 15, 2020
Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
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