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1480
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5359
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4322
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3248
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530
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2829
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4563
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4177
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1074
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1229
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15
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2406
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1995
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999
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546
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8334
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351
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996
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5431
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1347
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786
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698
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System, Imaging, Pulsed Doppler,...
632
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621
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Powered Laser Surgical Instrument
528
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
490
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System, Nuclear Magnetic...
485
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Intervertebral Fusion Device...
451
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Thoracolumbosacral Pedicle Screw...
443
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510k Database
Manufacturers
US
Invacare Corp.
Medical Device Manufacturer
·
US , Elyria , OH
Invacare Corp. - FDA 510(k) Cleared Devices
111 submissions
·
110 cleared
·
Since 1980
Official Website
111
Total
110
Cleared
0
Denied
29
devices
26-29 of 29
Filters
1
2
Cleared
Jul 29, 1985
PRIME AIRE O2 PLUS 2
K851437
·
CAW
Anesthesiology
·
110d
Cleared
Jul 29, 1985
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438
·
CAW
Anesthesiology
·
110d
Cleared
Jul 29, 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439
·
CAW
Anesthesiology
·
110d
Cleared
Jul 08, 1985
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436
·
CAF
Anesthesiology
·
89d
1
2
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111
Physical Medicine
76
Anesthesiology
29
General Hospital
4
Cardiovascular
1
Toxicology
1