510k
Database
Specialties
Anesthesiology
401
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1214
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303
Dental
911
Ear, Nose, Throat
173
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717
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1552
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938
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112
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79
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3
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395
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673
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292
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180
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2202
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42
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362
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1781
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137
Categories
GEX
Powered Laser Surgical Instrument
256
LLZ
System, Image Processing,...
239
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Automated Radiological Image...
232
IYN
System, Imaging, Pulsed Doppler,...
222
GEI
Electrosurgical, Cutting &...
218
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Osteomed Implantes, Ltda
Medical Device Manufacturer
·
BR , Rio Claro - Sp
Osteomed Implantes, Ltda - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteomed Implantes, Ltda
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 10, 2016
Anterior Cervical Plate System
K151553
·
KWQ
Orthopedic
·
246d
Cleared
Jun 10, 2015
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space...
K143572
·
ODP
Orthopedic
·
175d
Cleared
Jun 05, 2015
DPZ Pedicular Fixation System
K150294
·
MNI
Orthopedic
·
119d
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3
Orthopedic
3