510k
Database
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Anesthesiology
417
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1259
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311
Dental
958
Ear, Nose, Throat
181
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749
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1623
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1007
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114
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80
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6
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405
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702
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308
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189
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2282
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43
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379
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1840
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138
Categories
GEX
Powered Laser Surgical Instrument
272
LLZ
System, Image Processing,...
256
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Automated Radiological Image...
240
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System, Imaging, Pulsed Doppler,...
226
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
173
NKB
Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
153
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Nutek Orthopaedics, Inc.
Medical Device Manufacturer
·
US , Broward , FL
Nutek Orthopaedics, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2009
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nutek Orthopaedics, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
May 15, 2013
NBX - NON BRIDGING EXTERNAL FIXATOR HAND
K122777
·
KTT
Orthopedic
·
246d
Cleared
Feb 05, 2009
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
K082833
·
KTT
Orthopedic
·
132d
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Orthopedic
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