510k
Database
Specialties
Anesthesiology
535
Cardiovascular
1654
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2174
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
958
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Augustine Medical, Inc.
Medical Device Manufacturer
·
US , Eden Prairie , MN
Augustine Medical, Inc. - FDA 510(k) Cleared Devices
25 submissions
·
24 cleared
·
Since 1987
25
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Augustine Medical, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 28, 1994
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
K933726
·
LHC
General Hospital
·
179d
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25
Cardiovascular
13
Anesthesiology
8
General & Plastic Surgery
2
Hematology
1
General Hospital
1