510k
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Anesthesiology
452
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1378
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334
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1067
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196
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816
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1801
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1235
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122
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85
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7
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420
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769
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339
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215
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2429
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45
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413
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1989
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143
Categories
GEX
Powered Laser Surgical Instrument
294
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System, Image Processing,...
285
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Electrosurgical, Cutting &...
254
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Automated Radiological Image...
252
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
207
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Medivision Medical Imaging, Ltd.
Medical Device Manufacturer
·
US , Hopkinton , MA
Medivision Medical Imaging, Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1995
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medivision Medical Imaging, Ltd.
Ophthalmic
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 20, 2006
IRI INTEGRATED RETINAL IMAGER
K062295
·
HKI
Ophthalmic
·
74d
Cleared
Nov 17, 1995
ANGIOVISION VIEWING STATION
K953972
·
HKI
Ophthalmic
·
86d
Cleared
Nov 17, 1995
ANGIOVISION 1000
K953973
·
HKI
Ophthalmic
·
86d
Filters
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4
Ophthalmic
3
Radiology
1