510k
Database
Specialties
Anesthesiology
1013
Cardiovascular
4321
Chemistry
3204
Dental
2745
Ear, Nose, Throat
464
Gastroenterology & Urology
2306
General & Plastic Surgery
3925
General Hospital
3575
Hematology
779
Immunology
774
Medical Genetics
15
Microbiology
1404
Neurology
1755
Obstetrics & Gynecology
854
Ophthalmic
492
Orthopedic
7529
Pathology
165
Physical Medicine
958
Radiology
4604
Toxicology
1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
558
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
461
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
392
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
US
Esa, Inc.
Medical Device Manufacturer
·
US , Bedford , MA
Esa, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1987
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Esa, Inc.
Toxicology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 09, 1997
LEADCARE BLOOD LEAD TESTING SYSTEM
K971640
·
DOF
Toxicology
·
130d
Cleared
Sep 27, 1990
COULOCHEM II
K903231
·
LEQ
Toxicology
·
66d
Filters
Filter by Specialty
All
7
Chemistry
5
Toxicology
2