510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
Gastroenterology & Urology
973
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
279
Orthopedic
2934
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Medisonic U.S.A., Inc.
Medical Device Manufacturer
·
US , Clarence , NY
Medisonic U.S.A., Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1989
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medisonic U.S.A., Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 27, 1993
MEDISONIC OXYGEN FLOW CONTROLLER
K923660
·
NFB
Anesthesiology
·
189d
Cleared
May 22, 1990
MEDISONIC HUMDIFIER/INHALER
K901114
·
CAF
Anesthesiology
·
76d
Cleared
Jan 03, 1990
MEDISONIC PNEU-NEB
K896192
·
CAF
Anesthesiology
·
70d
Cleared
Nov 24, 1989
MEDISONIC ULTRA-SONIC INHALER
K894961
·
CAF
Anesthesiology
·
109d
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5
Anesthesiology
4
General Hospital
1