510k
Database
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Anesthesiology
1037
Cardiovascular
4339
Chemistry
3222
Dental
2789
Ear, Nose, Throat
465
Gastroenterology & Urology
2373
General & Plastic Surgery
4091
General Hospital
3725
Hematology
789
Immunology
776
Medical Genetics
15
Microbiology
1498
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1755
Obstetrics & Gynecology
876
Ophthalmic
495
Orthopedic
7543
Pathology
165
Physical Medicine
963
Radiology
4605
Toxicology
1238
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
568
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
392
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Manufacturers
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Manufacturers
US
Ellman Intl., Inc.
Medical Device Manufacturer
·
US , Hewlett , NY
Ellman Intl., Inc. - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 1996
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ellman Intl., Inc.
Dental
✕
1
devices
1-1 of 1
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Cleared
Apr 15, 1996
DENTO-SURGE
K955176
·
EKZ
Dental
·
154d
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15
General & Plastic Surgery
12
Ophthalmic
1
Dental
1
Obstetrics & Gynecology
1