510k
Database
Specialties
Anesthesiology
201
Cardiovascular
729
Chemistry
187
Dental
457
Ear, Nose, Throat
86
Gastroenterology & Urology
387
General & Plastic Surgery
757
General Hospital
465
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76
Immunology
62
Medical Genetics
1
Microbiology
273
Neurology
291
Obstetrics & Gynecology
113
Ophthalmic
75
Orthopedic
1467
Pathology
26
Physical Medicine
150
Radiology
1077
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
164
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
104
GEI
Electrosurgical, Cutting &...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Spire, Inc. D/B/A Spire Health
Medical Device Manufacturer
·
US , San Francisco , CA
Spire, Inc. D/B/A Spire Health - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2020
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Spire, Inc. D/B/A Spire Health
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 05, 2020
Spire Health Remote Patient Monitoring System
K192952
·
MSX
Cardiovascular
·
228d
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Cardiovascular
1