510k
Database
Specialties
Anesthesiology
540
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1660
Chemistry
362
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1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2177
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
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462
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960
Obstetrics & Gynecology
433
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274
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2846
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52
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515
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2417
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Nuvo- Group , Ltd.
Medical Device Manufacturer
·
IL , Tel Aviv
Nuvo- Group , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nuvo- Group , Ltd.
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
May 06, 2022
Invu by Nuvo
K221046
·
LQK
Obstetrics & Gynecology
·
28d
Cleared
May 28, 2021
INVU by Nuvo
K210025
·
LQK
Obstetrics & Gynecology
·
144d
Cleared
Mar 27, 2020
PregSense
K191401
·
LQK
Obstetrics & Gynecology
·
308d
Filters
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3
Obstetrics & Gynecology
3