510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1693
Chemistry
370
Dental
1348
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2206
General Hospital
2053
Hematology
126
Immunology
100
Medical Genetics
8
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473
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980
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438
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280
Orthopedic
2978
Pathology
52
Physical Medicine
515
Radiology
2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
398
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Leadtek Research, Inc.
Medical Device Manufacturer
·
TW , New Taipei City
Leadtek Research, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
Official Website
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Leadtek Research, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 01, 2021
Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter...
K210032
·
DQA
Anesthesiology
·
239d
Cleared
Apr 27, 2020
Leadtek Fingertip Pulse Oximeter
K193350
·
DQA
Anesthesiology
·
146d
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Anesthesiology
2