510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1418
Chemistry
334
Dental
1119
Ear, Nose, Throat
209
Gastroenterology & Urology
836
General & Plastic Surgery
1876
General Hospital
1386
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
808
Obstetrics & Gynecology
355
Ophthalmic
234
Orthopedic
2468
Pathology
48
Physical Medicine
429
Radiology
2049
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
GEI
Electrosurgical, Cutting &...
259
LZA
Polymer Patient Examination Glove
257
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Esaote Biomedica Spa
Medical Device Manufacturer
·
US , Cambridge , MA
Esaote Biomedica Spa - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1990
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Esaote Biomedica Spa
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 11, 1990
PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
K902368
·
DPS
Cardiovascular
·
105d
Cleared
Jun 26, 1990
MONITOR, MODEL 2817
K902334
·
DXJ
Cardiovascular
·
33d
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4
Cardiovascular
2
Radiology
1
Neurology
1