510k
Database
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1081
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4374
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3249
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2793
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467
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2400
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4109
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3801
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803
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782
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15
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1608
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1755
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878
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495
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7543
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166
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963
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4616
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1239
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727
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689
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568
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
520
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
Aircast, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Aircast, Inc. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 1978
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aircast, Inc.
Physical Medicine
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 14, 1993
AUTOCHILL ACCESSORY KIT
K925677
·
ILO
Physical Medicine
·
272d
Cleared
Aug 13, 1981
AIRCAST PNEUMATIC KNEE BRACE
K812094
·
ITQ
Physical Medicine
·
20d
Cleared
Feb 12, 1981
AIRCAST TENNIS ARM BAND
K810288
·
IQI
Physical Medicine
·
10d
Cleared
Jun 30, 1978
AIRSTIRRUP PNEUMATIC ANKLE BRACE
K780979
·
IQI
Physical Medicine
·
21d
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11
Cardiovascular
7
Physical Medicine
4