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1290
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4662
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3348
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2802
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474
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2457
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4191
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3863
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808
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796
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15
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1914
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1780
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890
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497
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8058
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167
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964
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4941
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1242
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735
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696
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570
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System, Imaging, Pulsed Doppler,...
538
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Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
517
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
447
MAX
Intervertebral Fusion Device...
435
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Thoracolumbosacral Pedicle Screw...
402
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Manufacturers
US
Planmeca USA, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Planmeca USA, Inc. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1984
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Planmeca USA, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 23, 2011
PLANMED NUANCE EXCEL
K111361
·
MUE
Radiology
·
130d
Cleared
Mar 04, 1993
ADMARK
K923533
·
JAC
Radiology
·
231d
Cleared
Apr 18, 1991
PLANMED SOPHIE
K904953
·
IZH
Radiology
·
164d
Cleared
Nov 26, 1986
DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
K864474
·
EHD
Radiology
·
13d
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13
Dental
8
Radiology
4
Anesthesiology
1