The following new items were added to the CDRH web pages on March 22, 2018. Previous CDRH New items can be found on the CDRH New webpage.
- Unintended Heating Associated with the Monteris Medical NeuroBlate Probe: Letter to Health Care Providers
- Monteris Medical NeuroBlate System Recalled Due to Unexpected Heating of Laser Delivery Probes
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170029 added)
- Safety Issue on Magellan Diagnostics LeadCare Testing Systems
- Press Release: Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues