Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1376053505
Device Listing 1376053505
Listing Summary
#
Listing key
1376053505
Premarket submission
K133780
Device
SPEED XL
Applicant
Biomedical Ent., Inc.
Product code
JDR
Decision date
2014-03-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
23899
8030965
3002807305
SYNTHES GMBH / Synthes Produktions GmbH
1
N
2026-01-01
EIMATTSTRASSE 3 Oberdorf, Baselland Basel-Landschaft CH CH-4436