510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1581
Chemistry
355
Dental
1270
Ear, Nose, Throat
233
Gastroenterology & Urology
920
General & Plastic Surgery
2106
General Hospital
1834
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
923
Obstetrics & Gynecology
419
Ophthalmic
265
Orthopedic
2677
Pathology
49
Physical Medicine
506
Radiology
2289
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
377
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
258
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Sandstone Medical (Suzhou), Inc.
Medical Device Manufacturer
·
CN , Suzhou
Sandstone Medical (Suzhou), Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sandstone Medical (Suzhou), Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 25, 2026
Easydrip Classic Pen Needle
K252908
·
FMI
General Hospital
·
194d
Cleared
Feb 17, 2022
Safety Pen Needle
K210864
·
FMI
General Hospital
·
331d
Cleared
Feb 02, 2021
Easydrip Pen Needle, Easydrip Plus Pen Needle
K193422
·
FMI
General Hospital
·
421d
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3
General Hospital
3