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1480
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5359
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4311
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3248
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530
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2829
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4562
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4175
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1074
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1228
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15
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2406
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1995
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994
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546
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8334
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347
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996
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5409
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1339
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System, Image Processing,...
780
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698
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632
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Electrosurgical, Cutting &...
621
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Powered Laser Surgical Instrument
528
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522
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Polymer Patient Examination Glove
490
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System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
451
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Thoracolumbosacral Pedicle Screw...
443
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510k Database
Manufacturers
US
Atos Medical AB
Medical Device Manufacturer
·
US , Potomac , MD
Atos Medical AB - FDA 510(k) Cleared Devices
15 submissions
·
14 cleared
·
Since 1990
15
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Atos Medical AB
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 12, 2016
ProTrach Dualcare
K151404
·
JOH
Anesthesiology
·
262d
Cleared
May 30, 2008
PROVOX MICRON HME
K072582
·
JOH
Anesthesiology
·
260d
Cleared
Feb 21, 2002
PROVOX HME CASSETTE, MODEL 7240
K014102
·
JOH
Anesthesiology
·
70d
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15
Ear, Nose, Throat
9
General & Plastic Surgery
3
Anesthesiology
3