510k
Database
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Anesthesiology
545
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1695
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373
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1351
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250
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979
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2213
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2062
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126
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100
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8
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474
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980
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438
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282
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2987
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52
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515
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2466
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155
Categories
LZA
Polymer Patient Examination Glove
414
LLZ
System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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358
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Passy & Passy, Inc.
Medical Device Manufacturer
·
US , Irvine , CA
Passy & Passy, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1985
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Passy & Passy, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 04, 1990
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
K903699
·
JOH
Anesthesiology
·
20d
Cleared
Jun 07, 1985
PASSY-MUIR TRACH VALVE
K851016
·
BTO
Anesthesiology
·
87d
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2
Anesthesiology
2