510k
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Anesthesiology
950
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3049
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1092
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2067
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376
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1873
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3426
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3312
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278
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247
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15
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1043
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1479
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734
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469
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4902
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80
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669
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4117
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335
Categories
LLZ
System, Image Processing,...
701
GEX
Powered Laser Surgical Instrument
510
IYN
System, Imaging, Pulsed Doppler,...
501
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Electrosurgical, Cutting &...
485
LZA
Polymer Patient Examination Glove
483
HRS
Plate, Fixation, Bone
435
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
391
LNH
System, Nuclear Magnetic...
345
NKB
Thoracolumbosacral Pedicle Screw...
343
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Manufacturers
GB
Hidalgo Limited
Medical Device Manufacturer
·
GB , Swavesey Cambridge
Hidalgo Limited - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2006
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hidalgo Limited
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 17, 2012
EQUIVITAL
K113054
·
MHX
Cardiovascular
·
127d
Cleared
Nov 03, 2006
EQUIVITAL, MODEL EQ-01
K061993
·
MHX
Cardiovascular
·
112d
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Cardiovascular
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