4 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
FDA Enforcement
Class II
·Terminated·Tenex Health Inc·May 14, 2014
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020