510k
Database
Specialties
Anesthesiology
505
Cardiovascular
1571
Chemistry
355
Dental
1249
Ear, Nose, Throat
232
Gastroenterology & Urology
910
General & Plastic Surgery
2085
General Hospital
1732
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
444
Neurology
913
Obstetrics & Gynecology
417
Ophthalmic
265
Orthopedic
2663
Pathology
49
Physical Medicine
501
Radiology
2265
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
345
GEX
Powered Laser Surgical Instrument
345
LLZ
System, Image Processing,...
345
GEI
Electrosurgical, Cutting &...
289
QIH
Automated Radiological Image...
271
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
FXX
Mask, Surgical
213
NHA
Abutment, Implant, Dental,...
204
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New Aera, Inc.
Medical Device Manufacturer
·
US , San Ramon , CA
New Aera, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2016
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - New Aera, Inc.
Anesthesiology
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 02, 2016
TAV System
K152664
·
ONZ
Anesthesiology
·
442d
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Anesthesiology
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