510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1295
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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
19
Total
17
Cleared
0
Denied
FDA 510(k) cleared devices by 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
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19
Cardiovascular
16
Dental
2
Radiology
1