510k
Database
Specialties
Anesthesiology
1702
Cardiovascular
5943
Chemistry
4869
Dental
3376
Ear, Nose, Throat
549
Gastroenterology & Urology
2944
General & Plastic Surgery
4765
General Hospital
4289
Hematology
1102
Immunology
1381
Medical Genetics
15
Microbiology
2619
Neurology
2010
Obstetrics & Gynecology
1079
Ophthalmic
562
Orthopedic
8580
Pathology
361
Physical Medicine
1086
Radiology
5712
Toxicology
1453
Categories
LLZ
System, Image Processing,...
820
HRS
Plate, Fixation, Bone
701
GEI
Electrosurgical, Cutting &...
700
IYN
System, Imaging, Pulsed Doppler,...
634
LNH
System, Nuclear Magnetic...
549
GEX
Powered Laser Surgical Instrument
545
JWH
Prosthesis, Knee,...
543
LZA
Polymer Patient Examination Glove
497
MAX
Intervertebral Fusion Device...
465
JAK
System, X-ray, Tomography, Computed
451
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Btl
Medical Device Manufacturer
·
US , Malborough , MA
Btl - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2019
Recent clearances:
BTL-899ST
,
BTL-703-2
,
BTL-785F
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Btl
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 26, 2021
BTL-899ST
K202199
·
GEI
General & Plastic Surgery
·
174d
Cleared
Aug 21, 2020
BTL-785F
K193201
·
GEI
General & Plastic Surgery
·
275d
Cleared
Dec 05, 2019
BTL-899
K192224
·
GEI
General & Plastic Surgery
·
111d
Filters
Filter by Specialty
All
4
General & Plastic Surgery
3
Physical Medicine
1