510k
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Anesthesiology
525
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1626
Chemistry
356
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1304
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237
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941
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2143
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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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943
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430
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272
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2757
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52
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515
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2355
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155
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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
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Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
Medical Device Manufacturer
·
US , El Dorado Hills , CA
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics - FDA 51...
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 02, 2026
Tahoe Unicondylar Knee System with TiNbN Overcoat
K260796
·
HSX
Orthopedic
·
22d
Cleared
Nov 20, 2025
TaperSet™ Hip System
K252846
·
LPH
Orthopedic
·
73d
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2
Orthopedic
2