510k
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Anesthesiology
415
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1254
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310
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954
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181
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745
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1607
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1001
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114
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80
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6
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403
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700
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308
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187
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2271
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43
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378
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1832
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138
Categories
GEX
Powered Laser Surgical Instrument
268
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System, Image Processing,...
256
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Automated Radiological Image...
237
IYN
System, Imaging, Pulsed Doppler,...
226
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
187
NHA
Abutment, Implant, Dental,...
172
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
153
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Biodex Medical Systems, Inc.
Medical Device Manufacturer
·
US , Shirley , NY
Biodex Medical Systems, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
8 cleared
·
Since 1994
9
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biodex Medical Systems, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 25, 2007
SHARPS CONTAINER, MODEL 039-413
K063666
·
MMK
General Hospital
·
45d
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9
Physical Medicine
6
Radiology
2
General Hospital
1