510k
Database
Specialties
Anesthesiology
417
Cardiovascular
1257
Chemistry
310
Dental
957
Ear, Nose, Throat
181
Gastroenterology & Urology
749
General & Plastic Surgery
1617
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1005
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114
Immunology
80
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6
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405
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702
Obstetrics & Gynecology
308
Ophthalmic
189
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2273
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43
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379
Radiology
1837
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
271
LLZ
System, Image Processing,...
256
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Automated Radiological Image...
239
IYN
System, Imaging, Pulsed Doppler,...
226
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
187
NHA
Abutment, Implant, Dental,...
172
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
153
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Danish Diagnostic Development A/S
Medical Device Manufacturer
·
DK , 2970 Horshom
Danish Diagnostic Development A/S - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2000
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Danish Diagnostic Development A/S
Radiology
✕
6
devices
1-6 of 6
Filters
Cleared
Jul 11, 2008
CAPIMAGE
K081829
·
IYX
Radiology
·
14d
Cleared
Jun 15, 2005
C.CAM-AC
K051460
·
KPS
Radiology
·
12d
Cleared
Mar 24, 2004
CARDIOMD-AC
K040616
·
KPS
Radiology
·
15d
Cleared
Jun 20, 2003
C.CAM
K031825
·
KPS
Radiology
·
7d
Cleared
Jun 08, 2001
CARDIOCAM MODEL 9CSY0799
K011611
·
KPS
Radiology
·
14d
Cleared
Jun 30, 2000
UNICORN MODEL SYS0630
K001888
·
KPS
Radiology
·
15d
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6
Radiology
6