510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1722
Chemistry
385
Dental
1380
Ear, Nose, Throat
254
Gastroenterology & Urology
986
General & Plastic Surgery
2224
General Hospital
2091
Hematology
127
Immunology
101
Medical Genetics
8
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474
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985
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443
Ophthalmic
283
Orthopedic
3053
Pathology
52
Physical Medicine
515
Radiology
2499
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
417
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Biosurge, Inc.
Medical Device Manufacturer
·
US , Rochester , NY
Biosurge, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1987
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biosurge, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 12, 1988
BIOSURGE MODEL OASYS-II
K875023
·
CAC
Anesthesiology
·
70d
Cleared
May 21, 1987
BIOSURGE MODEL OASYS
K871258
·
CAC
Anesthesiology
·
51d
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5
Anesthesiology
2
General Hospital
2
Cardiovascular
1