510k
Database
Specialties
Anesthesiology
521
Cardiovascular
1607
Chemistry
356
Dental
1299
Ear, Nose, Throat
234
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1972
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
939
Obstetrics & Gynecology
425
Ophthalmic
271
Orthopedic
2694
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52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
402
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
345
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Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Guilin Woodpecker Medical Instrument Co., Ltd.
Medical Device Manufacturer
·
US , Flintville , TN
Guilin Woodpecker Medical Instrument Co., Ltd. - FDA 510(k) Cleared D...
14 submissions
·
14 cleared
·
Since 2006
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guilin Woodpecker Medical Instrument Co., Ltd.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 04, 2025
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438
·
EHD
Radiology
·
118d
Cleared
Nov 23, 2022
Ai Ray Dental X-Ray Device
K222569
·
EHD
Radiology
·
91d
Cleared
Sep 27, 2021
Imaging Plate Scanner, i-Scan
K212080
·
MUH
Radiology
·
87d
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14
Dental
11
Radiology
3