510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
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168
Obstetrics & Gynecology
61
Ophthalmic
49
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1294
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18
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86
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870
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Electrocore, Inc.
Medical Device Manufacturer
·
US , Basking Ridge , NJ
Electrocore, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Electrocore, Inc.
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 10, 2021
gammaCore Sapphire
K211856
·
PKR
Neurology
·
86d
Cleared
Feb 12, 2021
gammaCore Sapphire
K203546
·
PKR
Neurology
·
70d
Cleared
Mar 26, 2020
gammaCore Sapphire
K191830
·
PKR
Neurology
·
261d
Cleared
Nov 27, 2018
gammaCore Sapphire
K182369
·
PKR
Neurology
·
88d
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4
Neurology
4