510k
Database
Specialties
Anesthesiology
327
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1055
Chemistry
267
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791
Ear, Nose, Throat
147
Gastroenterology & Urology
617
General & Plastic Surgery
1300
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741
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97
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72
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1
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364
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556
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240
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154
Orthopedic
2022
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38
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308
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1561
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129
Categories
GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
207
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System, Imaging, Pulsed Doppler,...
205
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Automated Radiological Image...
203
LLZ
System, Image Processing,...
196
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
167
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
132
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Cayenne Medical, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Cayenne Medical, Inc. - FDA 510(k) Cleared Devices
22 submissions
·
22 cleared
·
Since 2006
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cayenne Medical, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 04, 2012
CROSSFIX II MEMISCAL REPAIR DEVICE
K121413
·
GAT
General & Plastic Surgery
·
24d
Cleared
Jan 16, 2009
DUAL NEEDLE SUTURE PASSER SYSTEM
K082518
·
GAT
General & Plastic Surgery
·
136d
Cleared
Oct 19, 2007
CAPSEW PLICATION SYSTEM
K071796
·
GAT
General & Plastic Surgery
·
109d
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22
Orthopedic
19
General & Plastic Surgery
3