510k
Database
Specialties
Anesthesiology
141
Cardiovascular
581
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
296
General & Plastic Surgery
536
General Hospital
384
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
68
Ophthalmic
52
Orthopedic
1303
Pathology
18
Physical Medicine
88
Radiology
888
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Btl
Medical Device Manufacturer
·
US , Malborough , MA
Btl - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2019
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by 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
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4
General & Plastic Surgery
3
Physical Medicine
1