510k
Database
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Anesthesiology
505
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1571
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355
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1249
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232
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910
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2085
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1732
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126
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91
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8
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444
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913
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417
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265
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2663
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49
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501
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2265
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154
Categories
LZA
Polymer Patient Examination Glove
345
GEX
Powered Laser Surgical Instrument
345
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System, Image Processing,...
345
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Electrosurgical, Cutting &...
289
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Automated Radiological Image...
271
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
FXX
Mask, Surgical
213
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Abutment, Implant, Dental,...
204
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Pulmone Advanced Medical Devices, Ltd.
Medical Device Manufacturer
·
US , Gaithersburg , MD
Pulmone Advanced Medical Devices, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pulmone Advanced Medical Devices, Ltd.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 21, 2016
MiniBox +
K161295
·
BZC
Anesthesiology
·
165d
Cleared
Mar 06, 2015
PULMONE MINIBOXPFT 2.0
K141793
·
BZG
Anesthesiology
·
247d
Cleared
May 02, 2014
PULMONE MINIBOX PFT TM
K133051
·
BZC
Anesthesiology
·
217d
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3
Anesthesiology
3