510k
Database
Specialties
Anesthesiology
464
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1403
Chemistry
334
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1094
Ear, Nose, Throat
202
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827
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1840
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1313
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124
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86
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7
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420
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787
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351
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222
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2449
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47
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420
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2024
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144
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GEX
Powered Laser Surgical Instrument
300
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System, Image Processing,...
297
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Electrosurgical, Cutting &...
256
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Automated Radiological Image...
254
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
230
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
170
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Keystone X-Ray, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Keystone X-Ray, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1981
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Keystone X-Ray, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 23, 1993
INTREX VSK INTERORAL DENTAL X-RAY UNIT
K931486
·
EAP
Radiology
·
244d
Cleared
Jul 13, 1993
INTREX INTERORAL DENTAL X-RAY UNIT
K930925
·
EAP
Radiology
·
140d
Cleared
Dec 21, 1988
VARIABLE KV INTREX VSK 60 - 90 KVP
K883354
·
EAP
Radiology
·
134d
Cleared
Sep 16, 1981
FLUORO AUTOMATIC BRIGHTNESS SYS
K812217
·
JAA
Radiology
·
42d
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4
Radiology
4