510k
Database
Specialties
Anesthesiology
456
Cardiovascular
1388
Chemistry
334
Dental
1080
Ear, Nose, Throat
198
Gastroenterology & Urology
822
General & Plastic Surgery
1819
General Hospital
1261
Hematology
124
Immunology
85
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7
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420
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777
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343
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218
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2436
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46
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416
Radiology
2006
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
291
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
237
LZA
Polymer Patient Examination Glove
216
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Miles Inc., Agfa Division
Medical Device Manufacturer
·
US , Ridgefield Park , NJ
Miles Inc., Agfa Division - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1994
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Miles Inc., Agfa Division
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
May 12, 1995
DI-2000
K943602
·
IYX
Radiology
·
291d
Cleared
Sep 30, 1994
DIGITAL I.D. CAMERA
K942883
·
JAC
Radiology
·
105d
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2
Radiology
2