510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1623
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
941
General & Plastic Surgery
2143
General Hospital
2013
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
Neurology
942
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2757
Pathology
52
Physical Medicine
515
Radiology
2355
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Medtecs (Taiwan) Corp.
Medical Device Manufacturer
·
TW , Taipei City
Medtecs (Taiwan) Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtecs (Taiwan) Corp.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 21, 2022
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU...
K210414
·
FYC
General Hospital
·
617d
Cleared
Mar 02, 2022
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number:...
K203376
·
FXX
General Hospital
·
470d
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2
General Hospital
2