510k
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1012
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4313
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3201
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2736
Ear, Nose, Throat
464
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2287
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3889
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3553
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778
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774
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15
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1404
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1728
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851
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492
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7445
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163
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958
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4597
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1235
Categories
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System, Image Processing,...
725
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Plate, Fixation, Bone
688
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Electrosurgical, Cutting &...
549
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
449
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
388
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Manufacturers
CN
Avita Corporation
Medical Device Manufacturer
·
CN , New Taipei City
Avita Corporation - FDA 510(k) Cleared Devices
26 submissions
·
26 cleared
·
Since 2000
Official Website
26
Total
26
Cleared
0
Denied
26
devices
26-26 of 26
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1
2
Cleared
Dec 29, 2000
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182
·
FLL
General Hospital
·
163d
1
2
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26
General Hospital
11
Cardiovascular
9
Anesthesiology
3
Gastroenterology & Urology
1
Ear, Nose, Throat
1
General & Plastic Surgery
1