FDA.reportPublic FDA data

Engineered-Medical-Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099733363009973336Engineered Medical Systems, LLC1N2026-01-013325 Appling Rd Bartlett TN US 38133
30152598583015259858Engineered Medical Systems Baltimore1N2020-04-25101 West Dickman St. Suite 900 Baltimore MD US 21230

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2254911803121618K131877SAVE II, SAVE II BASICBTL2014-03-21
1493201001148382
1493201004913502
1493201010959265
1493201016998059
1493201023783189
1493201031320169
1493201035208740
1493201038686491
1493201039590753
1493201040794003
1493201040833394
1493201048268399
1493201052796429
1493201058203528
1493201078354202
1493201082206475
1493201099756188
1493201100327390
1493201101041900
1493201129725038
1493201132480610
1493201133496337
1493201146271978
1493201147520060
1493201148044463
1493201149059037
1493201155361954
1493201170420199
1493201185642720
1493201186099339
1493201208715027
1493201230422241
1493201254609177
1493201263968990
1493201267967000
1493201278508271
1493201304008578
1493201308778980
1493201311672126
1493201317908160
1493201318811581
1493201322641937
1493201329786115
1493201352226195
1493201359739005
1493201382294180
1493201399401358
1493201403677609
1493201413062941
1493201415988398
1493201462141216
1493201467087025
1493201467729721
1493201483631609
1493201495080300
1493201500444731
1493201500503671
1493201526675450
1493201527808019
1493201528057549
1493201550797317
1493201564775556
1493201574944742
1493201583143016
1493201593425945
1493201599865455
1493201656113213
1493201659731101
1493201661855251
1493201674311358
1493201683580301
1493201723074882
1493201794531615
1493201798401503
1493201806188008
1493201807178158
1493201813030729
1493201819370167
1493201822883120
1493201835066799
1493201841728342
1493201848867701
1493201895908761
1493201900811485
1493201910709319
1493201914485120
1493201923250351
1493201924311266
1493201926683589
1493201949870723
1493201962221670
1493201965576052
1493201967794911
1493201974387085
1493201979465604
1493201982917101
1493201989326098
1493201994285152
1493201994877928
1493202001743941
1493202017470687
1493202019709524
1493202033428386
1493202037328754
1493202041784137
1493202043747539
1493202066830954
1493202070899488
1493202072593165

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BTL12014-03-21

PMN#

TRACH VOX

2002-07-30

ENGINEERED MEDICAL SYSTEMS

GUDID#

80 records. Showing 1-40. Next