510k
Database
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Anesthesiology
525
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1613
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356
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1304
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235
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930
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2136
General Hospital
1991
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126
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91
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8
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449
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942
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429
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272
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2705
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52
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515
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2353
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155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
263
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Guangzhou Hehong Biotech Co., Ltd.
Medical Device Manufacturer
·
CN , Guangzhou
Guangzhou Hehong Biotech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guangzhou Hehong Biotech Co., Ltd.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 12, 2026
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175,...
K253354
·
MQF
Obstetrics & Gynecology
·
135d
Cleared
Feb 03, 2025
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY,...
K241454
·
MQK
Obstetrics & Gynecology
·
257d
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2
Obstetrics & Gynecology
2