510k
Database
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Anesthesiology
694
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2123
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466
Dental
1714
Ear, Nose, Throat
309
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1215
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2667
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2399
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151
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132
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13
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578
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1202
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552
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364
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3780
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57
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574
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2993
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172
Categories
LLZ
System, Image Processing,...
497
LZA
Polymer Patient Examination Glove
452
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Powered Laser Surgical Instrument
436
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Electrosurgical, Cutting &...
391
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Mask, Surgical
386
IYN
System, Imaging, Pulsed Doppler,...
360
HRS
Plate, Fixation, Bone
348
MAX
Intervertebral Fusion Device...
306
OLO
Orthopedic Stereotaxic Instrument
286
QIH
Automated Radiological Image...
285
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Manufacturers
US
Steiner Laboratories
Medical Device Manufacturer
·
US , Kapolei , HI
Steiner Laboratories - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Steiner Laboratories
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 06, 2016
ORAL BOND
K142130
·
EMA
Dental
·
672d
Cleared
Jan 27, 2012
SOCKET GRAFT
K113049
·
LYC
Dental
·
106d
Cleared
Nov 28, 2006
REGEN BIOCEMENT
K063010
·
LYC
Dental
·
57d
Cleared
Jun 09, 2006
SOCKET GRAFT
K052493
·
LYC
Dental
·
270d
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4
Dental
4