510k
Database
Specialties
Anesthesiology
370
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1174
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285
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873
Ear, Nose, Throat
159
Gastroenterology & Urology
686
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1473
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865
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108
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76
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1
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385
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642
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266
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171
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2166
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41
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349
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1714
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135
Categories
GEX
Powered Laser Surgical Instrument
248
QIH
Automated Radiological Image...
224
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System, Imaging, Pulsed Doppler,...
221
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System, Image Processing,...
219
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
207
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Advanced Instrumentations, Inc.
Medical Device Manufacturer
·
US , Hialeah , FL
Advanced Instrumentations, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 2009
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Advanced Instrumentations, Inc.
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 19, 2014
FM-3000 FETAL MONITOR
K141194
·
HGM
Obstetrics & Gynecology
·
195d
Cleared
Dec 21, 2011
FM-9000 PLUS FETAL AND MATERNAL MONITOR
K112317
·
HGM
Obstetrics & Gynecology
·
132d
Cleared
Sep 21, 2011
CMS-1000FM CENTRAL MONITORING SYSTEM
K112159
·
HGM
Obstetrics & Gynecology
·
56d
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16
Radiology
7
Cardiovascular
5
Obstetrics & Gynecology
3
Anesthesiology
1