510k
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Anesthesiology
525
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1614
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356
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1304
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237
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937
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2142
General Hospital
2013
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126
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91
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8
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458
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942
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429
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272
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2757
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52
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515
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2354
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Piper Access, LLC
Medical Device Manufacturer
·
US , Salt Lake City , UT
Piper Access, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Piper Access, LLC
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 27, 2021
Stiletto Extended Dwell Catheter
K210047
·
PND
General Hospital
·
231d
Cleared
Nov 13, 2019
Piper GO-IO Intraosseous Infusion System
K191976
·
FMI
General Hospital
·
112d
Cleared
Sep 25, 2018
5 FR Dual Lumen Piper PICC
K181904
·
LJS
General Hospital
·
71d
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3
General Hospital
3