510k
Database
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Anesthesiology
411
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1252
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309
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950
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181
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739
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1606
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995
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113
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80
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6
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402
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695
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303
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186
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2263
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43
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378
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1825
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138
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GEX
Powered Laser Surgical Instrument
267
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System, Image Processing,...
255
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Automated Radiological Image...
237
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System, Imaging, Pulsed Doppler,...
225
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Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
150
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Isodose Control B.V.
Medical Device Manufacturer
·
NL , Veenendaal
Isodose Control B.V. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2007
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Isodose Control B.V.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
May 27, 2009
FLEXIPLAN 3D AND 3D+
K091145
·
MUJ
Radiology
·
37d
Cleared
Oct 30, 2008
APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
K082530
·
JAQ
Radiology
·
58d
Cleared
Jul 29, 2008
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
K081112
·
MUJ
Radiology
·
102d
Cleared
Apr 13, 2007
FLEXITRON
K070574
·
JAQ
Radiology
·
44d
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4
Radiology
4