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Anesthesiology
3533
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9865
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8536
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5955
Ear, Nose, Throat
1958
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5164
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8156
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6614
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1983
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2529
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16
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4769
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2891
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1863
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1457
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12324
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635
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1595
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8242
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2132
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Powered Laser Surgical Instrument
1352
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Electrosurgical, Cutting &...
1168
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System, Image Processing,...
1133
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Plate, Fixation, Bone
933
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System, Nuclear Magnetic...
818
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System, Imaging, Pulsed Doppler,...
793
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Prosthesis, Knee,...
787
ESD
Hearing Aid, Air-conduction,...
740
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Laparoscope, General & Plastic...
706
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Implant, Endosseous, Root-form
675
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510k Database
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