510k
Database
Specialties
Anesthesiology
484
Cardiovascular
1470
Chemistry
339
Dental
1159
Ear, Nose, Throat
216
Gastroenterology & Urology
850
General & Plastic Surgery
1922
General Hospital
1459
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
829
Obstetrics & Gynecology
367
Ophthalmic
246
Orthopedic
2527
Pathology
49
Physical Medicine
447
Radiology
2085
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
265
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
248
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
207
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Fibra Sonics, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Fibra Sonics, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1980
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fibra Sonics, Inc.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 22, 1999
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
K993046
·
FEO
Gastroenterology & Urology
·
73d
Cleared
Dec 11, 1984
ULTRASONIC LITHOTRIPTOR 300A
K842024
·
FEO
Gastroenterology & Urology
·
207d
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10
Ophthalmic
3
Gastroenterology & Urology
2
General & Plastic Surgery
2
Radiology
1
Physical Medicine
1
Dental
1