510k
Database
Specialties
Anesthesiology
532
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1643
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359
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1318
Ear, Nose, Throat
242
Gastroenterology & Urology
955
General & Plastic Surgery
2169
General Hospital
2036
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126
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97
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8
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462
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952
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Roosin Medical Co., Ltd.
Medical Device Manufacturer
·
CN , Taizhou
Roosin Medical Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roosin Medical Co., Ltd.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 11, 2024
Copper Foam Dressing (Prescription and OTC)
K231088
·
FRO
General & Plastic Surgery
·
269d
Cleared
Nov 17, 2023
Polyver Silver Alginate Dressing (Prescription and OTC)
K230190
·
FRO
General & Plastic Surgery
·
297d
Cleared
Sep 13, 2019
Roosin Xeroform Petrolatum Dressing
K181478
·
FRO
General & Plastic Surgery
·
465d
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3
General & Plastic Surgery
3