510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1636
Chemistry
358
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
947
General & Plastic Surgery
2157
General Hospital
2023
Hematology
126
Immunology
95
Medical Genetics
8
Microbiology
459
Neurology
949
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2796
Pathology
52
Physical Medicine
515
Radiology
2371
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Sorin Biomedical, Inc.
Medical Device Manufacturer
·
US , Irvine , CA
Sorin Biomedical, Inc. - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 1993
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sorin Biomedical, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 20, 1998
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
K963758
·
CAC
Anesthesiology
·
520d
Cleared
Feb 20, 1998
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
K963759
·
CAC
Anesthesiology
·
520d
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15
Cardiovascular
13
Anesthesiology
2