510k
Database
Specialties
Anesthesiology
540
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1660
Chemistry
362
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1329
Ear, Nose, Throat
244
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957
General & Plastic Surgery
2182
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2039
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126
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97
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8
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464
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962
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433
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274
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2862
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52
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515
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2418
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
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...
219
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A Cute Baby, Inc.
Medical Device Manufacturer
·
US , Orem , UT
A Cute Baby, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - A Cute Baby, Inc.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 12, 2026
Mini Moon electric breast pump (PA221)
K252583
·
HGX
Obstetrics & Gynecology
·
209d
Cleared
Apr 17, 2020
Rumble Tuff Electric Breast Pump
K200712
·
HGX
Obstetrics & Gynecology
·
30d
Filters
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2
Obstetrics & Gynecology
2