510k
Database
Specialties
Anesthesiology
201
Cardiovascular
729
Chemistry
187
Dental
457
Ear, Nose, Throat
86
Gastroenterology & Urology
387
General & Plastic Surgery
757
General Hospital
465
Hematology
77
Immunology
62
Medical Genetics
1
Microbiology
273
Neurology
292
Obstetrics & Gynecology
113
Ophthalmic
75
Orthopedic
1467
Pathology
26
Physical Medicine
150
Radiology
1077
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
164
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
104
GEI
Electrosurgical, Cutting &...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Phakos
Medical Device Manufacturer
·
FR , Montreuil
Phakos - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Phakos
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 02, 2020
MIRA Adapter
K200911
·
HRN
Ophthalmic
·
57d
Cleared
Oct 25, 2018
Endocular Viewing Lenses and Silicone Ring
K173944
·
HJK
Ophthalmic
·
303d
Cleared
Mar 16, 2018
Frigitronics adapter
K180195
·
HRN
Ophthalmic
·
51d
Cleared
May 03, 2017
PHAKOS Disposable Retinal Cryo Probe
K162756
·
HRN
Ophthalmic
·
215d
Filters
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4
Ophthalmic
4