510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1729
Chemistry
386
Dental
1400
Ear, Nose, Throat
257
Gastroenterology & Urology
994
General & Plastic Surgery
2237
General Hospital
2097
Hematology
127
Immunology
104
Medical Genetics
8
Microbiology
474
Neurology
985
Obstetrics & Gynecology
444
Ophthalmic
286
Orthopedic
3076
Pathology
52
Physical Medicine
515
Radiology
2510
Toxicology
156
Categories
LZA
Polymer Patient Examination Glove
422
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
366
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
312
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
237
MAX
Intervertebral Fusion Device...
234
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Lite-Med, Inc.
Medical Device Manufacturer
·
TW , Taipei City
Lite-Med, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2011
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lite-Med, Inc.
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 19, 2023
LM-9300 Plus Lithotripter
K213772
·
LNS
Gastroenterology & Urology
·
413d
Cleared
Mar 20, 2015
LM-9300 ELMA Lithotripter
K142561
·
LNS
Gastroenterology & Urology
·
190d
Cleared
Sep 28, 2011
LITE-MED LM-9200 ELMA
K103217
·
LNS
Gastroenterology & Urology
·
331d
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3
Gastroenterology & Urology
3