510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1722
Chemistry
385
Dental
1380
Ear, Nose, Throat
254
Gastroenterology & Urology
986
General & Plastic Surgery
2224
General Hospital
2091
Hematology
127
Immunology
101
Medical Genetics
8
Microbiology
474
Neurology
985
Obstetrics & Gynecology
443
Ophthalmic
283
Orthopedic
3053
Pathology
52
Physical Medicine
515
Radiology
2499
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
417
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Diatek, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Diatek, Inc. - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 1979
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diatek, Inc.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
May 09, 2002
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
K020430
·
NFK
Gastroenterology & Urology
·
90d
Cleared
Aug 14, 2001
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC,...
K010399
·
MSD
Gastroenterology & Urology
·
186d
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15
General Hospital
10
Anesthesiology
3
Gastroenterology & Urology
2