510k
Database
Specialties
Anesthesiology
361
Cardiovascular
1139
Chemistry
284
Dental
854
Ear, Nose, Throat
153
Gastroenterology & Urology
669
General & Plastic Surgery
1415
General Hospital
834
Hematology
105
Immunology
76
Medical Genetics
1
Microbiology
376
Neurology
627
Obstetrics & Gynecology
259
Ophthalmic
165
Orthopedic
2141
Pathology
40
Physical Medicine
342
Radiology
1673
Toxicology
133
Categories
GEX
Powered Laser Surgical Instrument
241
QIH
Automated Radiological Image...
221
HRS
Plate, Fixation, Bone
216
IYN
System, Imaging, Pulsed Doppler,...
216
LLZ
System, Image Processing,...
208
GEI
Electrosurgical, Cutting &...
195
OLO
Orthopedic Stereotaxic Instrument
179
NHA
Abutment, Implant, Dental,...
166
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
145
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Arthrex, Inc.
Medical Device Manufacturer
·
US , Naples , FL
Arthrex, Inc. - FDA 510(k) Cleared Devices
346 submissions
·
342 cleared
·
Since 1992
Official Website
346
Total
342
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arthrex, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
May 16, 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124
·
FMF
General Hospital
·
33d
Cleared
Sep 29, 2006
ARTHREX ASPIRATE KIT
K062365
·
FMF
General Hospital
·
46d
Cleared
Nov 29, 2005
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
K052387
·
LZB
General Hospital
·
90d
Filters
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346
Orthopedic
307
General & Plastic Surgery
36
General Hospital
3