510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1693
Chemistry
370
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2211
General Hospital
2055
Hematology
126
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100
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8
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473
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980
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438
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280
Orthopedic
2980
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52
Physical Medicine
515
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2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
411
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
361
FXX
Mask, Surgical
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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Dawn Medical
Medical Device Manufacturer
·
US , San Francisco , CA
Dawn Medical - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1991
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dawn Medical
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 25, 1991
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
K904117
·
BZG
Anesthesiology
·
172d
Cleared
Feb 25, 1991
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.
K904118
·
BZG
Anesthesiology
·
172d
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4
Anesthesiology
2
Gastroenterology & Urology
1
General & Plastic Surgery
1