510k
Database
Specialties
Anesthesiology
467
Cardiovascular
1405
Chemistry
334
Dental
1104
Ear, Nose, Throat
204
Gastroenterology & Urology
828
General & Plastic Surgery
1852
General Hospital
1332
Hematology
124
Immunology
86
Medical Genetics
7
Microbiology
420
Neurology
793
Obstetrics & Gynecology
352
Ophthalmic
226
Orthopedic
2453
Pathology
47
Physical Medicine
422
Radiology
2027
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
297
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
235
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Koven and Assoc., Inc.
Medical Device Manufacturer
·
US , St. Louis , MO
Koven and Assoc., Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1989
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Koven and Assoc., Inc.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 10, 1992
MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR
K915550
·
DPW
Radiology
·
365d
Cleared
Dec 23, 1991
MODEL HD-207 BIDIRECTIONAL VELOCITY METER
K912409
·
JOP
Radiology
·
206d
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8
Cardiovascular
6
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2