510k
Database
Specialties
Anesthesiology
379
Cardiovascular
1185
Chemistry
288
Dental
878
Ear, Nose, Throat
163
Gastroenterology & Urology
691
General & Plastic Surgery
1486
General Hospital
876
Hematology
108
Immunology
77
Medical Genetics
1
Microbiology
387
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646
Obstetrics & Gynecology
273
Ophthalmic
172
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2175
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41
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350
Radiology
1724
Toxicology
135
Categories
GEX
Powered Laser Surgical Instrument
250
QIH
Automated Radiological Image...
228
LLZ
System, Image Processing,...
222
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
208
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Anzai Medical Co., Ltd.
Medical Device Manufacturer
·
US , Brookeville , MD
Anzai Medical Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2002
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Anzai Medical Co., Ltd.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 05, 2017
Anzai Respiratory Gating System
K170719
·
LHN
Radiology
·
27d
Cleared
Apr 22, 2016
Anzai Respiratory Gating System
K160432
·
LHN
Radiology
·
66d
Cleared
Nov 10, 2003
ANZAI AZ-733 RESPIRATORY GATING SYSTEM
K031385
·
LHN
Radiology
·
193d
Cleared
Oct 09, 2002
EZ-SCOPE AN, EZ-SCOPE LIGHT
K022342
·
IYX
Radiology
·
83d
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4
Radiology
4