510k
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Anesthesiology
540
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1660
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362
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1323
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244
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957
General & Plastic Surgery
2179
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2039
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126
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97
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8
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464
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960
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433
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274
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2846
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52
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515
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2417
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Suzhou Leapmed Healthcare Corporation
Medical Device Manufacturer
·
CN , Suzhou
Suzhou Leapmed Healthcare Corporation - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suzhou Leapmed Healthcare Corporation
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 06, 2022
Disposable Biopsy Refill Needle
K212819
·
FCG
General & Plastic Surgery
·
306d
Cleared
Jul 06, 2022
Disposable Semi Automatic Biopsy Instrument
K212820
·
KNW
General & Plastic Surgery
·
306d
Cleared
Jul 06, 2022
Disposable Coaxial Biopsy Needle
K212822
·
FCG
General & Plastic Surgery
·
306d
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4
General & Plastic Surgery
3
Gastroenterology & Urology
1