FDA.reportPublic FDA data

BLACK FOREST MEDICAL NORTH AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039235793003923579BLACK FOREST MEDICAL NORTH AMERICA, INC.1Y2026-01-014529 SE 16th Place, Suite 101 Cape Coral FL US 33904

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
192371652655919K203505DORO QR3 Headrest System (Aluminum)HBL2021-03-29
192371894492559K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)HBL2020-06-02
192371110750546K191979DORO QR3 XTom Headholder SystemHBL2019-10-22
192371652132676K191740DORO LUCENT® iXI and iMRI Headrest SystemHBL2020-02-21
192371494081499K063494DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTSHBL2007-05-21
192371610987686K032331DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)HBL2003-11-20
192372056266647K001808DORO HEADREST SYSTEMHBL2000-08-04
192371714908519

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HBL72021-03-29