510k
Database
Specialties
Anesthesiology
8950
Cardiovascular
18092
Chemistry
13184
Dental
12603
Ear, Nose, Throat
3787
Gastroenterology & Urology
9870
General & Plastic Surgery
18301
General Hospital
17768
Hematology
3267
Immunology
3784
Medical Genetics
20
Microbiology
7060
Neurology
6302
Obstetrics & Gynecology
4504
Ophthalmic
5100
Orthopedic
18001
Pathology
1106
Physical Medicine
5442
Radiology
15621
Toxicology
3016
Categories
Powered Laser Surgical Instrument
GEX
2893
Electrosurgical, Cutting &...
GEI
2311
System, Image Processing, Radiological
LLZ
2294
Latex Patient Examination Glove
LYY
1954
Implant, Endosseous, Root-form
DZE
1548
Laparoscope, General & Plastic Surgery
GCJ
1432
Hearing Aid, Air-conduction,...
ESD
1348
Plate, Fixation, Bone
HRS
1332
System, Measurement,...
DXN
1207
System, Imaging, Pulsed Doppler,...
IYN
1187
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
BTL Industries, Inc.
Share
Medical Device Manufacturer
·
US , Malborough , MA
BTL Industries, Inc. - FDA 510(k) Cleared Devices
44 submissions
·
44 cleared
·
Since 2010
Recent clearances:
BTL-299-F
,
BTL-699
,
BTL-899TT
View 44 510(k) Devices ↓
Official Website
44
Total
44
Cleared
0
Denied
FDA 510(k) Regulatory Record - BTL Industries, Inc.
Neurology
✕
5
devices
1-5 of 5
Filters
Cleared
Aug 23, 2026
BTL-699
K260691
·
OBP
Neurology
·
173d
Cleared
Dec 13, 2024
BTL-785BNF-E
K242532
·
NFO
Neurology
·
109d
Cleared
Feb 01, 2024
BTL-99-OC
K230657
·
QCI
Neurology
·
329d
Cleared
Sep 18, 2023
BTL-785BNF Handpiece
K232172
·
NFO
Neurology
·
59d
Cleared
Mar 04, 2022
BTL-995-rTMS
K212723
·
OBP
Neurology
·
189d
Filters
Filter by Specialty
All
44
General & Plastic Surgery
20
Physical Medicine
13
Neurology
5
Gastroenterology & Urology
4
Dental
1
Cardiovascular
1