510k
Database
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Anesthesiology
452
Cardiovascular
1378
Chemistry
334
Dental
1067
Ear, Nose, Throat
196
Gastroenterology & Urology
816
General & Plastic Surgery
1801
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1235
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122
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85
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7
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420
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769
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339
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215
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2429
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45
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413
Radiology
1989
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143
Categories
GEX
Powered Laser Surgical Instrument
294
LLZ
System, Image Processing,...
285
GEI
Electrosurgical, Cutting &...
254
QIH
Automated Radiological Image...
252
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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Cardio Metrics, Inc.
Medical Device Manufacturer
·
US , Houston , TX
Cardio Metrics, Inc. - FDA 510(k) Cleared Devices
23 submissions
·
23 cleared
·
Since 1986
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardio Metrics, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 14, 1986
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
K863482
·
GCY
General & Plastic Surgery
·
35d
Filters
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23
Cardiovascular
17
Radiology
5
General & Plastic Surgery
1