510k
Database
Specialties
Anesthesiology
198
Cardiovascular
720
Chemistry
185
Dental
450
Ear, Nose, Throat
86
Gastroenterology & Urology
382
General & Plastic Surgery
750
General Hospital
460
Hematology
74
Immunology
61
Medical Genetics
1
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271
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287
Obstetrics & Gynecology
111
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75
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1464
Pathology
26
Physical Medicine
145
Radiology
1067
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
106
GEI
Electrosurgical, Cutting &...
103
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Sysmed (China) Co., Ltd.
Medical Device Manufacturer
·
CN , Shenyang
Sysmed (China) Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Sysmed (China) Co., Ltd.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 25, 2020
SysMed S/T
K192177
·
BZD
Anesthesiology
·
471d
Cleared
Jun 01, 2018
Oxygen Concentrator
K172234
·
CAW
Anesthesiology
·
311d
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Anesthesiology
2