510k
Database
Specialties
Anesthesiology
204
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740
Chemistry
187
Dental
471
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
777
General Hospital
476
Hematology
77
Immunology
64
Medical Genetics
1
Microbiology
277
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305
Obstetrics & Gynecology
118
Ophthalmic
80
Orthopedic
1479
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26
Physical Medicine
153
Radiology
1098
Toxicology
94
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
127
LLZ
System, Image Processing,...
125
QIH
Automated Radiological Image...
113
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Fairhaven Health, LLC
Medical Device Manufacturer
·
US , Bellingham , WA
Fairhaven Health, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Fairhaven Health, LLC
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 16, 2019
Sage 2-in-1 Personal Lubricant and Moisturizer
K190150
·
NUC
Obstetrics & Gynecology
·
167d
Cleared
Apr 28, 2017
BabyDance Fertility Lubricant
K162319
·
PEB
Obstetrics & Gynecology
·
252d
Filters
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2
Obstetrics & Gynecology
2