510k
Database
Specialties
Anesthesiology
505
Cardiovascular
1572
Chemistry
355
Dental
1253
Ear, Nose, Throat
233
Gastroenterology & Urology
910
General & Plastic Surgery
2087
General Hospital
1740
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
444
Neurology
914
Obstetrics & Gynecology
417
Ophthalmic
265
Orthopedic
2666
Pathology
49
Physical Medicine
501
Radiology
2269
Toxicology
154
Categories
LLZ
System, Image Processing,...
347
LZA
Polymer Patient Examination Glove
346
GEX
Powered Laser Surgical Instrument
345
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
271
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
219
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
Browse all 339 categories →
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Sdi Diagnostics, Inc.
Medical Device Manufacturer
·
US , North Easton , MA
Sdi Diagnostics, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1993
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sdi Diagnostics, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 21, 1993
PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER
K934509
·
CAH
General Hospital
·
37d
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10
Anesthesiology
9
General Hospital
1