510k
Database
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Anesthesiology
557
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1742
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387
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1411
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258
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1010
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2264
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2113
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127
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105
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8
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478
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999
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462
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292
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3116
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52
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520
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2534
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156
Categories
LZA
Polymer Patient Examination Glove
424
LLZ
System, Image Processing,...
408
GEX
Powered Laser Surgical Instrument
372
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Mask, Surgical
361
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Electrosurgical, Cutting &...
319
IYN
System, Imaging, Pulsed Doppler,...
307
HRS
Plate, Fixation, Bone
301
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
241
MAX
Intervertebral Fusion Device...
239
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Manufacturers
US
Airlife, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Airlife, Inc. - FDA 510(k) Cleared Devices
76 submissions
·
76 cleared
·
Since 1979
76
Total
76
Cleared
0
Denied
FDA 510(k) Regulatory Record - Airlife, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 27, 1979
TEMPO2-I DISPOSABLE THERMOMETERS
K790890
·
FQZ
General Hospital
·
51d
Cleared
Jun 27, 1979
TEMPO2-II DISPOSABLE THERMOMETERS
K790891
·
FLK
General Hospital
·
51d
Filters
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76
Anesthesiology
71
Cardiovascular
3
General Hospital
2