510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1626
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
941
General & Plastic Surgery
2148
General Hospital
2015
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
Neurology
946
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2762
Pathology
52
Physical Medicine
515
Radiology
2356
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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American Biosystems, Inc.
Medical Device Manufacturer
·
US , Marine On St. Croix , MN
American Biosystems, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1988
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Biosystems, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 21, 2000
ABI VEST AIRWAY CLEARANCE SYSTEM
K993629
·
BYI
Anesthesiology
·
86d
Cleared
Jun 24, 1997
THAIRAPY VEST SYSTEM
K965192
·
BYI
Anesthesiology
·
182d
Cleared
Aug 02, 1994
THAIRAPY SYSTEM
K936121
·
BYI
Anesthesiology
·
222d
Cleared
Dec 16, 1988
THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101
K884098
·
BYI
Anesthesiology
·
79d
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4
Anesthesiology
4