510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1580
Chemistry
355
Dental
1268
Ear, Nose, Throat
233
Gastroenterology & Urology
919
General & Plastic Surgery
2105
General Hospital
1826
Hematology
126
Immunology
91
Medical Genetics
8
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448
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921
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419
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265
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2675
Pathology
49
Physical Medicine
505
Radiology
2288
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
375
LLZ
System, Image Processing,...
355
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
253
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Dixtal Medical, Inc.
Medical Device Manufacturer
·
US , Wallingford , CT
Dixtal Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2010
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dixtal Medical, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 25, 2011
DIXTAL DZ-4100 SERIES PULSE OXIMETER
K103285
·
DQA
Anesthesiology
·
259d
Cleared
Mar 08, 2010
DX SERIES FINGER SENSOR
K100020
·
DQA
Anesthesiology
·
62d
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Anesthesiology
2