510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2179
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
464
Neurology
960
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2846
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Konica Minolta Healthcare Americas, Inc.
Medical Device Manufacturer
·
US , Garner , NC
Konica Minolta Healthcare Americas, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2020
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Konica Minolta Healthcare Americas, Inc.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Jul 27, 2022
OTC DDR
K221853
·
KPR
Radiology
·
30d
Cleared
Jan 21, 2022
Universal DR 1748
K214030
·
MQB
Radiology
·
29d
Cleared
Jan 12, 2022
Straight Arm DDR
K214012
·
KPR
Radiology
·
21d
Cleared
Dec 10, 2021
EXA
K203743
·
LLZ
Radiology
·
353d
Cleared
Jan 15, 2020
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU...
K193225
·
KPR
Radiology
·
54d
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5
Radiology
5