510k
Database
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Anesthesiology
550
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1722
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385
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1380
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254
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986
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2224
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2091
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127
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101
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8
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474
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985
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443
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283
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3053
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52
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515
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2499
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155
Categories
LZA
Polymer Patient Examination Glove
417
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
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Mask, Surgical
359
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Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Reganes, Inc.
Medical Device Manufacturer
·
US , Clearwater , FL
Reganes, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1985
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Reganes, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 11, 1988
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
K880181
·
CAZ
Anesthesiology
·
27d
Cleared
Dec 19, 1985
EPIDURAL ANESTHESIA NEEDLES
K854816
·
BSP
Anesthesiology
·
16d
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Anesthesiology
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