510k
Database
Specialties
Anesthesiology
489
Cardiovascular
1486
Chemistry
342
Dental
1170
Ear, Nose, Throat
216
Gastroenterology & Urology
857
General & Plastic Surgery
1937
General Hospital
1481
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
845
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2561
Pathology
49
Physical Medicine
455
Radiology
2116
Toxicology
148
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
310
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
262
IYN
System, Imaging, Pulsed Doppler,...
254
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
212
NHA
Abutment, Implant, Dental,...
199
MAX
Intervertebral Fusion Device...
178
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Bio-Tech Co.
Medical Device Manufacturer
·
US , Washington , IA
Bio-Tech Co. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1990
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio-Tech Co.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 20, 1992
FX-CABLELOK SYSTEM
K922142
·
JDQ
Orthopedic
·
198d
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2
Orthopedic
1
Physical Medicine
1