510k
Database
Specialties
Anesthesiology
530
Cardiovascular
1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
240
Gastroenterology & Urology
950
General & Plastic Surgery
2164
General Hospital
2029
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
950
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2808
Pathology
52
Physical Medicine
515
Radiology
2384
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 &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
223
MAX
Intervertebral Fusion Device...
207
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Deka Research and Development
Medical Device Manufacturer
·
US , Manchester , NH
Deka Research and Development - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 2015
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Deka Research and Development
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 12, 2024
Remunity System
K240256
·
QJY
General Hospital
·
133d
Cleared
Mar 01, 2024
DEKA Infusion System, DEKA Administration Set
K232316
·
LDR
General Hospital
·
211d
Cleared
Dec 30, 2020
Remunity Pump for Remodulin (treprostinil) Injection
K202690
·
QJY
General Hospital
·
106d
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11
Chemistry
5
Gastroenterology & Urology
3
General Hospital
3