6 results
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8ms
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Sources: EU EUDAMED, US FDA
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
FDA Enforcement
Class II
·Terminated·MRP, LLC dba AMUSA·September 2, 2015
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
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 2, 2016
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014