510k
Database
Specialties
Anesthesiology
452
Cardiovascular
1372
Chemistry
334
Dental
1064
Ear, Nose, Throat
195
Gastroenterology & Urology
814
General & Plastic Surgery
1792
General Hospital
1227
Hematology
121
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85
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7
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420
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768
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338
Ophthalmic
215
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2429
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44
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411
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1984
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143
Categories
GEX
Powered Laser Surgical Instrument
293
LLZ
System, Image Processing,...
285
GEI
Electrosurgical, Cutting &...
254
QIH
Automated Radiological Image...
251
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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Dexcom, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Dexcom, Inc. - FDA 510(k) Cleared Devices
24 submissions
·
21 cleared
·
Since 2014
Official Website
24
Total
21
Cleared
3
Denied
FDA 510(k) Regulatory Record - Dexcom, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 23, 2024
Dexcom G7 Continuous Glucose Monitoring System
K240902
·
QBJ
General & Plastic Surgery
·
21d
Cleared
CT
Feb 26, 2024
Dexcom G7 Continuous Glucose Monitoring System
K234133
·
QBJ
General & Plastic Surgery
·
59d
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24
Chemistry
22
General & Plastic Surgery
2