FDA.reportPublic FDA data

Bayer HealthCare, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22432522243252Bayer HealthCare, LLC1N2026-01-0136 Columbia Rd Morristown NJ US 07960

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1887361802181199P020014ESSURE SYSTEMHHS2002-11-04
1887361463413124K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXT2004-12-10
1887362019301403

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HHS22002-11-04
DXT12004-12-10

PMA#

PMN#