FDA.reportPublic FDA data

FOCAL THERAPEUTICS

Matched from indexed company URL: Focal Therapeutics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097182123009718212FOCAL THERAPEUTICS1N2020-04-251010 Stewart Dr Sunnyvale CA US 94085

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851766006023BioZorb Marker - The Marker is a radiographic implantable marker used to mark soft tissue.It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.855-764-7258customerservice@focalrx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1433051005627514K171467BioZorb Marker GOLD / LP Marker GOLDIYE2017-11-09
1433051999673638K152070BioZorb LP MarkerNEU2015-08-26
1433051316752566K143484BioZorb MarkerNEU2015-06-29
1433051124902042
1433051959190765

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEU22015-08-26
IYE12017-11-09

PMN#

GUDID#