510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1672
Chemistry
364
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
969
General & Plastic Surgery
2190
General Hospital
2046
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2912
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Nanowear, Inc.
Medical Device Manufacturer
·
US , Brooklyn , NY
Nanowear, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nanowear, Inc.
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 08, 2023
SimpleSense-BP, SimpleSense-BP Software Application
K232053
·
DXN
Cardiovascular
·
150d
Cleared
Sep 22, 2021
SimpleSENSE Platform
K212160
·
DXH
Cardiovascular
·
72d
Cleared
Nov 06, 2020
SimpleSENSE
K201669
·
DXH
Cardiovascular
·
140d
Cleared
Nov 30, 2016
SimplECG
K161431
·
DXH
Cardiovascular
·
190d
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4
Cardiovascular
4