510k
Database
Specialties
Anesthesiology
198
Cardiovascular
720
Chemistry
185
Dental
450
Ear, Nose, Throat
86
Gastroenterology & Urology
382
General & Plastic Surgery
750
General Hospital
460
Hematology
74
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61
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1
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271
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287
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111
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75
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1464
Pathology
26
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145
Radiology
1067
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
106
GEI
Electrosurgical, Cutting &...
103
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Fulwell, LLC
Medical Device Manufacturer
·
US , Miami , FL
Fulwell, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Fulwell, LLC
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 24, 2020
RF Surgical Generator
K200931
·
GEI
General & Plastic Surgery
·
231d
Cleared
Jun 13, 2019
Electrosurgical Generator
K183564
·
GEI
General & Plastic Surgery
·
175d
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General & Plastic Surgery
2