510k
Database
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Anesthesiology
332
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1064
Chemistry
270
Dental
806
Ear, Nose, Throat
148
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623
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1322
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758
Hematology
99
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72
Medical Genetics
1
Microbiology
365
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579
Obstetrics & Gynecology
244
Ophthalmic
155
Orthopedic
2054
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40
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309
Radiology
1582
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
229
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
208
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
156
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
135
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Flow Laboratories, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Flow Laboratories, Inc. - FDA 510(k) Cleared Devices
57 submissions
·
56 cleared
·
Since 1976
Official Website
57
Total
56
Cleared
0
Denied
FDA 510(k) Regulatory Record - Flow Laboratories, Inc.
Hematology
✕
1
devices
1-1 of 1
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Cleared
Mar 11, 1982
MONO-POLY RESOLVING MEDIUM
K812947
·
JCF
Hematology
·
142d
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57
Microbiology
31
Immunology
13
Chemistry
7
Pathology
5
Hematology
1