510k
Database
Specialties
Anesthesiology
204
Cardiovascular
736
Chemistry
187
Dental
465
Ear, Nose, Throat
91
Gastroenterology & Urology
392
General & Plastic Surgery
769
General Hospital
474
Hematology
77
Immunology
63
Medical Genetics
1
Microbiology
276
Neurology
297
Obstetrics & Gynecology
115
Ophthalmic
77
Orthopedic
1476
Pathology
26
Physical Medicine
152
Radiology
1084
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
GEX
Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Chien TI Enterprise Co., Ltd.
Medical Device Manufacturer
·
TW , New Taipei City, Hsin Chuang District
Chien TI Enterprise Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Chien TI Enterprise Co., Ltd.
Physical Medicine
✕
3
devices
1-3 of 3
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Cleared
Dec 09, 2019
C.T.M. Mobility Scooter HS-268
K192885
·
INI
Physical Medicine
·
60d
Cleared
Dec 14, 2018
C.T.M Mobility Scooter
K181344
·
INI
Physical Medicine
·
207d
Cleared
May 03, 2017
C.T.M. Mobility Scooter
K162952
·
INI
Physical Medicine
·
191d
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3
Physical Medicine
3