510k
Database
Specialties
Anesthesiology
538
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1656
Chemistry
360
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1323
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244
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957
General & Plastic Surgery
2176
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2039
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126
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97
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8
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462
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959
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433
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274
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2844
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52
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515
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2413
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Accriva Diagnostics, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Accriva Diagnostics, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Accriva Diagnostics, Inc.
Hematology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 29, 2021
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test...
K202101
·
JPA
Hematology
·
518d
Cleared
Nov 22, 2019
Hemochron Signature Elite
K193041
·
JPA
Hematology
·
22d
Filters
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3
Hematology
2
General & Plastic Surgery
1