510k
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325
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1045
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264
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783
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147
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609
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1290
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97
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72
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363
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553
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240
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148
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1987
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38
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307
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1548
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128
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GEX
Powered Laser Surgical Instrument
227
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System, Imaging, Pulsed Doppler,...
205
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Plate, Fixation, Bone
204
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Automated Radiological Image...
202
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System, Image Processing,...
191
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Electrosurgical, Cutting &...
181
OLO
Orthopedic Stereotaxic Instrument
166
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Abutment, Implant, Dental,...
151
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Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
130
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Zhongshan A&J Medical Equipment Co., Ltd.
Medical Device Manufacturer
·
CN , Guangdong
Zhongshan A&J Medical Equipment Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2007
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zhongshan A&J Medical Equipment Co., Ltd.
Physical Medicine
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 03, 2026
Electric Wheelchair (AL-208S-063)
K253340
·
ITI
Physical Medicine
·
185d
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4
Anesthesiology
2
General & Plastic Surgery
1
Physical Medicine
1