510k
Database
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Anesthesiology
547
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1714
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380
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1356
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252
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982
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2217
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2087
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126
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100
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8
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474
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980
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441
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283
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3042
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52
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515
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2492
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
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Powered Laser Surgical Instrument
363
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Mask, Surgical
359
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
295
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
232
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Changzhou Holymed Products Co., Ltd.
Medical Device Manufacturer
·
CN , Changhou
Changzhou Holymed Products Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Changzhou Holymed Products Co., Ltd.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 07, 2021
Surgical Mask
K210524
·
FXX
General Hospital
·
134d
Cleared
Dec 20, 2012
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM...
K121998
·
FYA
General Hospital
·
164d
Cleared
Dec 12, 2012
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
K122000
·
KKX
General Hospital
·
156d
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3
General Hospital
3