510k
Database
Specialties
Anesthesiology
429
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1299
Chemistry
327
Dental
1001
Ear, Nose, Throat
187
Gastroenterology & Urology
773
General & Plastic Surgery
1688
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1094
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117
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83
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7
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411
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730
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318
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198
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2356
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44
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393
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1888
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140
Categories
GEX
Powered Laser Surgical Instrument
279
LLZ
System, Image Processing,...
266
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Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
238
IYN
System, Imaging, Pulsed Doppler,...
231
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
193
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
MAX
Intervertebral Fusion Device...
161
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Arex USA
Medical Device Manufacturer
·
US , Collegeville , PA
Arex USA - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2008
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arex USA
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 17, 2010
LIGAMENTOTAXOR
K094043
·
HTY
Orthopedic
·
229d
Cleared
Nov 07, 2008
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25,...
K081011
·
HWC
Orthopedic
·
212d
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2
Orthopedic
2