510k
Database
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Anesthesiology
525
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1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
930
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2136
General Hospital
1991
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126
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91
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8
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449
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942
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429
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272
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2705
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52
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515
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2353
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155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
263
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Sim Italia S.R.L.
Medical Device Manufacturer
·
US , Great Neck , NY
Sim Italia S.R.L. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1996
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sim Italia S.R.L.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 25, 2003
TRAVELSOME STANDARD
K030233
·
CAW
Anesthesiology
·
92d
Cleared
Oct 03, 1997
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853...
K971947
·
CAW
Anesthesiology
·
128d
Cleared
Nov 01, 1996
INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
K963042
·
CAW
Anesthesiology
·
88d
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3
Anesthesiology
3