510k
Database
Specialties
Anesthesiology
430
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1306
Chemistry
327
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1004
Ear, Nose, Throat
190
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781
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1697
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1101
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117
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83
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7
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412
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732
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321
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199
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2365
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44
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393
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1898
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140
Categories
GEX
Powered Laser Surgical Instrument
281
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System, Image Processing,...
267
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Automated Radiological Image...
246
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Electrosurgical, Cutting &...
239
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System, Imaging, Pulsed Doppler,...
232
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
MAX
Intervertebral Fusion Device...
161
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Orthosonics, Ltd.
Medical Device Manufacturer
·
US , Brookeville , MD
Orthosonics, Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2002
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthosonics, Ltd.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 19, 2010
OSCAR 3
K093805
·
JDX
Orthopedic
·
70d
Cleared
Mar 20, 2009
OSCAR BONE RESECTOR
K083830
·
JDX
Orthopedic
·
87d
Cleared
Jul 21, 2005
OSCAR, MODEL OE3000DB
K051053
·
JDX
Orthopedic
·
87d
Cleared
Jun 06, 2002
OSCAR, MODEL OE3000
K021502
·
LZV
Orthopedic
·
28d
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4
Orthopedic
4