510k
Database
Specialties
Anesthesiology
140
Cardiovascular
574
Chemistry
167
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
293
General & Plastic Surgery
532
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
65
Ophthalmic
51
Orthopedic
1299
Pathology
18
Physical Medicine
88
Radiology
882
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
135
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Sleeping Well, LLC
Medical Device Manufacturer
·
US , Crofton , MD
Sleeping Well, LLC - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2009
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Sleeping Well, LLC
Dental
✕
6
devices
1-6 of 6
Filters
Cleared
Jun 15, 2022
ZQuiet Advance
K213088
·
LRK
Dental
·
264d
Cleared
Jun 12, 2018
ZQuiet
K180124
·
LRK
Dental
·
147d
Cleared
Jul 25, 2014
ZQUIET-SA
K140777
·
LRK
Dental
·
119d
Cleared
Dec 07, 2012
ZQUIET PRO-PLUS
K122475
·
LRK
Dental
·
115d
Cleared
Jun 22, 2010
ZQUIET MOUTHPIECE
K093407
·
LRK
Dental
·
232d
Cleared
Mar 10, 2009
ZQUIET MOUTHPIECE
K090503
·
LRK
Dental
·
13d
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6
Dental
6