510k
Database
Specialties
Anesthesiology
519
Cardiovascular
1600
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
927
General & Plastic Surgery
2126
General Hospital
1959
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
938
Obstetrics & Gynecology
425
Ophthalmic
271
Orthopedic
2691
Pathology
52
Physical Medicine
511
Radiology
2316
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
337
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Good Sleep CO Pte , Ltd.
Medical Device Manufacturer
·
SG , Singapore
Good Sleep CO Pte , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Good Sleep CO Pte , Ltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 25, 2025
Hushd Avera
K252161
·
LRK
Dental
·
138d
Cleared
Oct 24, 2025
Hushd Pro Z-Link
K251784
·
LRK
Dental
·
135d
Cleared
May 09, 2024
Hushd Pro Avera
K232025
·
LRK
Dental
·
307d
Filters
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3
Dental
3