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 →
Search
Reports
Glossary
About
Home
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.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 09, 1991
ABIODENT PERIOTEMP(R) SYSTEM
K911643
·
EIL
Dental
·
88d
Cleared
Feb 13, 1989
ABIOMED PERIOTEMP(TM) PROBE
K885075
·
EIL
Dental
·
67d
Filters
Filter by Specialty
All
19
Cardiovascular
16
Dental
2
Radiology
1