510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
930
General & Plastic Surgery
2136
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2729
Pathology
52
Physical Medicine
515
Radiology
2353
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
264
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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The Surgical Company International B.V.
Medical Device Manufacturer
·
NL , Beeldschermweg 6g
The Surgical Company International B.V. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - The Surgical Company International B.V.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 18, 2025
Fluido Compact System
K252636
·
LGZ
General Hospital
·
90d
Cleared
Jun 05, 2023
Fluido Compact Blood and Fluid Warming System
K211618
·
LGZ
General Hospital
·
740d
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3
General Hospital
2
Cardiovascular
1