4 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·October 30, 2013
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022