510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
967
General & Plastic Surgery
2190
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2045
Hematology
126
Immunology
97
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8
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466
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965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2910
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Biometrix , Ltd.
Medical Device Manufacturer
·
US , Greenwich , CT
Biometrix , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1993
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biometrix , Ltd.
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 04, 2015
Art-line Single channel blood pressure system, Art-line Double channel blood...
K151040
·
DRS
Cardiovascular
·
137d
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4
General Hospital
2
Cardiovascular
1
Anesthesiology
1