510k
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1330
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4923
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3553
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2814
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475
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2514
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4254
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3897
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865
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822
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15
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1930
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1841
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893
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498
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8086
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184
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978
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5179
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1293
Categories
LLZ
System, Image Processing,...
757
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Plate, Fixation, Bone
696
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System, Imaging, Pulsed Doppler,...
609
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Electrosurgical, Cutting &...
570
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
HWC
Screw, Fixation, Bone
404
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Manufacturers
GB
Medicsight
Medical Device Manufacturer
·
GB , London
Medicsight - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2003
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medicsight
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 19, 2004
COLON CAR 1.2
K042674
·
NWE
Radiology
·
20d
Cleared
Jul 22, 2004
LUNG CAR 1.1
K041807
·
OEB
Radiology
·
16d
Cleared
Dec 30, 2003
MEDICLUNG, RELEASE 1
K033412
·
OEB
Radiology
·
64d
Cleared
Nov 10, 2003
MEDICHEART, MODEL RELEASE 1
K032823
·
JAK
Radiology
·
61d
Cleared
Nov 05, 2003
MEDIC COLON MODEL, RELEASE 1
K033102
·
JAK
Radiology
·
37d
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Radiology
5