510k
Database
Specialties
Anesthesiology
467
Cardiovascular
1405
Chemistry
334
Dental
1101
Ear, Nose, Throat
203
Gastroenterology & Urology
828
General & Plastic Surgery
1846
General Hospital
1319
Hematology
124
Immunology
86
Medical Genetics
7
Microbiology
420
Neurology
787
Obstetrics & Gynecology
351
Ophthalmic
224
Orthopedic
2452
Pathology
47
Physical Medicine
421
Radiology
2025
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
297
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
232
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Bt Medical Co., Inc.
Medical Device Manufacturer
·
US , Irvine , CA
Bt Medical Co., Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1992
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bt Medical Co., Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 19, 1993
URETERAL COMPRESSION DEVICE
K931268
·
JAA
Radiology
·
133d
Cleared
Jul 13, 1993
PNEUMATIC COMPRESSION DEVICE
K930885
·
JAA
Radiology
·
145d
Cleared
Jun 02, 1993
LEAD APRON
K931269
·
EAJ
Radiology
·
86d
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5
Radiology
3
Physical Medicine
2