510k
Database
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Anesthesiology
327
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1055
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267
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791
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147
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617
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1300
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741
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97
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72
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1
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364
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556
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240
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154
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2022
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38
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308
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1561
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129
Categories
GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
207
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System, Imaging, Pulsed Doppler,...
205
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Automated Radiological Image...
203
LLZ
System, Image Processing,...
196
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
167
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
132
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Diagnostic Hybrids, Inc.
Medical Device Manufacturer
·
US , Athens , OH
Diagnostic Hybrids, Inc. - FDA 510(k) Cleared Devices
37 submissions
·
36 cleared
·
Since 1988
37
Total
36
Cleared
1
Denied
FDA 510(k) Regulatory Record - Diagnostic Hybrids, Inc.
Immunology
✕
2
devices
1-2 of 2
Filters
Cleared
May 18, 2010
THYRETAIN TM TSI REPORTER BIOASSAY
K092229
·
JZO
Immunology
·
299d
Cleared
May 21, 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391
·
JZO
Immunology
·
185d
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37
Microbiology
33
Pathology
2
Immunology
2