510k
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Anesthesiology
424
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1281
Chemistry
314
Dental
970
Ear, Nose, Throat
183
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753
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1642
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1045
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114
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82
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6
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406
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708
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315
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193
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2317
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43
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382
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1862
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139
Categories
GEX
Powered Laser Surgical Instrument
275
LLZ
System, Image Processing,...
259
QIH
Automated Radiological Image...
242
IYN
System, Imaging, Pulsed Doppler,...
229
HRS
Plate, Fixation, Bone
228
GEI
Electrosurgical, Cutting &...
227
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
176
LZA
Polymer Patient Examination Glove
160
NKB
Thoracolumbosacral Pedicle Screw...
158
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Leica Microsystems, Inc.
Medical Device Manufacturer
·
US , Park City , UT
Leica Microsystems, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1999
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Leica Microsystems, Inc.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 20, 2006
LEICA MODEL FL800
K061871
·
IZI
Radiology
·
79d
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2
Radiology
1
Ophthalmic
1