510k
Database
Specialties
Anesthesiology
531
Cardiovascular
1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
242
Gastroenterology & Urology
953
General & Plastic Surgery
2165
General Hospital
2031
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
950
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2812
Pathology
52
Physical Medicine
515
Radiology
2386
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
378
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
298
IYN
System, Imaging, Pulsed Doppler,...
280
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
224
MAX
Intervertebral Fusion Device...
208
Browse all 339 categories →
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About
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Abiomed, Inc.
Medical Device Manufacturer
·
US , Danvers , MA
Abiomed, Inc. - FDA 510(k) Cleared Devices
19 submissions
·
17 cleared
·
Since 1989
Official Website
19
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abiomed, Inc.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 15, 1990
ABIOMED BODY LEAD ANALYZER MODEL 200/20
K900574
·
JAO
Radiology
·
36d
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19
Cardiovascular
16
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2
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1