510k
Database
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Anesthesiology
527
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1632
Chemistry
356
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1304
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239
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946
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2156
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2020
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126
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92
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8
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459
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948
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430
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272
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2770
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52
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515
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2356
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Topcon Healthcare Solutions
Medical Device Manufacturer
·
US , Oakland , NJ
Topcon Healthcare Solutions - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2023
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Topcon Healthcare Solutions
Ophthalmic
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 20, 2023
Harmony
K232555
·
NFJ
Ophthalmic
·
89d
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Ophthalmic
1