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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA Adverse Event
Malfunction
·COVIDIEN·Product code OIJ·January 27, 2016
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code OIJ·May 19, 2016
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
FDA Recall
Terminated
·Hologic, Inc.·Product code OIJ·July 7, 2017
Biopsy Needle Guide Kit
FDA classification
FDA Class 2
·Biopsy Needle Guide Kit
BIOHIT OYJ
FDA registration
BIOHIT OYJ·1 product·🇫🇮 Finland
Nexstim NBS software
FDA UDI
Nexstim Oyj·06430063200002·NBS main software
Nexstim NBS Black Head Tracker
FDA UDI
Nexstim Oyj·06430063200125·Nexstim NBS Black Head Tracker (box of 4), new ...
Nexstim NBS software GER
FDA UDI
Nexstim Oyj·06430063200064·Nexstim NBS German Main Software
Nexstim NBS White Head Tracker
FDA UDI
Nexstim Oyj·06430063200194·Nexstim NBS White Head Tracker (box of 20). Par...
Nexstim NBS System
FDA UDI
Nexstim Oyj·06430063200057·Nexstim NBS System
Nexstim NBS Orange Head Tracker
FDA UDI
Nexstim Oyj·06430063200118·Nexstim NBS Orange Head Tracker (box of 20)
Ne...
Nexstim NBT system
FDA UDI
Nexstim Oyj·06430063200149·Nexstim NBT system
Nexstim Head Tracker Tape
FDA UDI
Nexstim Oyj·06430063200200·Nexstim Head Tracker Tape (box of 200). Part li...
Nexstim NBS System
FDA UDI
Nexstim Oyj·06430063200187·Nexstim NBS System 6
Nexstim Focal Coil
FDA UDI
Nexstim Oyj·06430063200088·Nexstim Focal Coil
Nexstim NBT software
FDA UDI
Nexstim Oyj·06430063200156·NBT main software
Modulight ML6710i Laser and ML-SLA
FDA UDI
Modulight Oyj·06429810677020·The intended use for the ML6710i laser is photo...
NexSpeech analyzer software
FDA UDI
Nexstim Oyj·06430063200033·NexSpeech Analyzer Software
Nexstim Cooled Coil
FDA UDI
Nexstim Oyj·06430063200095·Nexstim Cooled Coil
NexSpeech main software
FDA UDI
Nexstim Oyj·06430063200026·NexSpeech Main Software