510k
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488
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1482
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342
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1166
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216
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857
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1936
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1477
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125
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90
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433
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369
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250
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2552
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455
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2111
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147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
310
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Polymer Patient Examination Glove
286
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Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
261
IYN
System, Imaging, Pulsed Doppler,...
253
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Stony Brook Surgical Innovations, Inc.
Medical Device Manufacturer
·
US , Great Neck , NY
Stony Brook Surgical Innovations, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1993
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stony Brook Surgical Innovations, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 22, 2001
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
K013059
·
GAQ
General & Plastic Surgery
·
41d
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2
General & Plastic Surgery
1
Orthopedic
1