FDA.reportPublic FDA data

Btl

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30069763593006976359BTL Industries, Inc1Y2026-01-01362 Elm Street Marlborough MA US 01752
30353743863035374386BTL Industries JSC1N2026-01-01Vladaya 3 Plovdiv BG 4006
30073801153007380115BTLOCK International1N2020-04-25via Madonnetta 219 Montecchio Maggiore Vicenza IT 36075

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3352001680223098K250309BTL-199QPL2025-08-07
3352001701839759K243290BTL-785MJNUW2025-05-09
3352001866139475K242532BTL-785BNF-ENFO2024-12-13
3352001884060723K240234BTL-899MSIPF2024-08-17
3352001458186610K233604BTL-785SGEI2024-03-28
3352001305293682K230467BTL-899FGEI2023-09-21
3352001467065355K222556BTL-785XGEI2023-05-31
3352001103800579K213344BTL-899AGEI2022-01-05
3352001532359284K212723BTL-995-rTMSOBP2022-03-04
3352002018640965K211639BTL-785WGEI2022-03-07
3352001067261849K211107BTL-899 FPGEI2021-07-09
3352001197633803K202199BTL-899STGEI2021-01-26
3352001127066202K200382BTL-703-2NGX2021-01-06
3352001041975432K193201BTL-785FGEI2020-08-21
3352001369372700K192224BTL-899GEI2019-12-05
3352001952292227K190456BTL 799-2LNGX2019-07-05
3352001973943190K190023BTL-084PBX2019-03-29
3352001032793766K181497HPM-6000UFKPI2018-11-14
3352001324629465K163176Exilis XP IIPBX2017-01-12
3352001876331290K161551TR-100PBX2016-09-13
3352001163693505K152731XP1100 RFGEI2016-07-20
3352001997901136K150720XP3000PBX2015-09-16
3352001977000514K143559XP1000 RFGEI2015-06-11
3352001287982128K122966XP200GEI2013-04-08
3352001966611106K092191EXILIS, MODEL 5000GEI2009-11-25
971242019474366K083869BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISIDZE2009-03-27
971241865704090K073458BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)DZE2008-04-04
971241450909776
971241793680741
3352001328705890
3352001332593809
3352001741005317
3352002043154600

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI132024-03-28
PBX42019-03-29
NGX22021-01-06
DZE22009-03-27
QPL12025-08-07
NUW12025-05-09
NFO12024-12-13
IPF12024-08-17
OBP12022-03-04
KPI12018-11-14

PMN#

BTL-499

2024-04-23

BTL Industries, Inc.

BTL-094

2023-04-14

BTL Industries, Inc.

BTL-084

2019-03-29

BTL Industries, Inc.

BTL-703

2019-01-24

BTL Industries, Inc.

AM-100

2017-02-16

BTL INDUSTRIES, INC

TR-100

2016-09-13

BTL INDUSTRIES, INC.

XP3000

2015-09-16

BTL Industries, Inc.

Exilite

2015-04-08

BTL Industries, Inc.

XP300

2015-03-06

BTL INDUSTRIES, INC

XP200

2013-04-08

BTL INDUSTRIES LTD

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