510k
Database
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332
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1064
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270
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806
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148
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623
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1322
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758
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99
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72
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1
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365
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579
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244
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155
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2054
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40
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309
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1582
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132
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Powered Laser Surgical Instrument
229
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211
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
205
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System, Image Processing,...
199
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Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
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Abutment, Implant, Dental,...
156
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Intervertebral Fusion Device...
138
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Thoracolumbosacral Pedicle Screw...
135
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Newport Biosystems, Inc.
Medical Device Manufacturer
·
US , Santa Ana , CA
Newport Biosystems, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1985
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Newport Biosystems, Inc.
Pathology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 05, 1986
RPMI 1640 W/GLUTAMINE W/HEPES
K860282
·
KIT
Pathology
·
8d
Cleared
Jan 13, 1986
TISSUE CULTURE MEDIA
K855085
·
KIT
Pathology
·
24d
Cleared
Aug 26, 1985
FETAL BOVINE SERUM IN TRANSFER CONTAINER
K853441
·
KJA
Pathology
·
13d
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4
Pathology
3
Anesthesiology
1