510k
Database
Specialties
Anesthesiology
208
Cardiovascular
743
Chemistry
187
Dental
473
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
784
General Hospital
479
Hematology
77
Immunology
64
Medical Genetics
1
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278
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310
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121
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81
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1484
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26
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155
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1103
Toxicology
95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
113
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
98
NKB
Thoracolumbosacral Pedicle Screw...
93
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Specialty Appliance Works, Inc.
Medical Device Manufacturer
·
US , Marietta , GA
Specialty Appliance Works, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2007
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Specialty Appliance Works, Inc.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 03, 2019
Clear Image Aligners
K183643
·
NXC
Dental
·
8d
Cleared
Jan 27, 2009
ACRYLIC HERBST SPLINT APPLIANCE
K083209
·
LRK
Dental
·
88d
Cleared
Sep 25, 2007
CLEAR IMAGE ALIGNER
K071970
·
NXC
Dental
·
70d
Filters
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3
Dental
3