510k
Database
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Anesthesiology
506
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1577
Chemistry
355
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1262
Ear, Nose, Throat
233
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911
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2091
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1760
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126
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91
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8
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445
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916
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417
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265
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2672
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49
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502
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2275
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154
Categories
LZA
Polymer Patient Examination Glove
352
LLZ
System, Image Processing,...
347
GEX
Powered Laser Surgical Instrument
345
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Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
225
OLO
Orthopedic Stereotaxic Instrument
217
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Abutment, Implant, Dental,...
204
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Orsense, Ltd.
Medical Device Manufacturer
·
IL , Kfar Saba
Orsense, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orsense, Ltd.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 16, 2015
Pulse oximeter NBM-200
K142209
·
DQA
Anesthesiology
·
158d
Cleared
Oct 17, 2013
NBM-200MP
K124041
·
DQA
Anesthesiology
·
293d
Cleared
Mar 19, 2010
NBM-200MP PULSE OXIMETRY DEVICE
K091564
·
DQA
Anesthesiology
·
295d
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3
Anesthesiology
3