510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
933
General & Plastic Surgery
2142
General Hospital
1999
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2753
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
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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Wellmed Dental Medical Supply Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Wellmed Dental Medical Supply Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wellmed Dental Medical Supply Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 25, 2025
Self Sealing Sterilization Pouches
K243721
·
FRG
General Hospital
·
143d
Cleared
Nov 04, 2022
Disposable Medical Face Mask (DF3-001)
K222697
·
FXX
General Hospital
·
58d
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3
General Hospital
2
Dental
1