Biodex Medical Systems, Inc. - May 1, 2018
Issue Date
May 01, 2018
Region
Northeast
Category
Device
$117.00
Contact Name
James Reiss
Contact Title
President & CEO
Address 1
20 Ramsey Rd.
City
Shirley
State
NY
Zip/Postal Code
11967-4704
Country
United States
Inspection Range
Apr 24, 2018 - May 01, 2018
Pages
4
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Andrew Garufi and Jacqueline S. Warner