510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
Gastroenterology & Urology
975
General & Plastic Surgery
2196
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
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469
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965
Obstetrics & Gynecology
434
Ophthalmic
279
Orthopedic
2940
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52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
278
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Neotract, Inc.
Medical Device Manufacturer
·
US , Pleasanton , CA
Neotract, Inc. - FDA 510(k) Cleared Devices
17 submissions
·
16 cleared
·
Since 2006
17
Total
16
Cleared
1
Denied
FDA 510(k) Regulatory Record - Neotract, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 22, 2021
UroLift System Rigid Retrieval Kit Sterilization Tray
K212396
·
KCT
General Hospital
·
81d
Cleared
Apr 14, 2020
UroLift System Procedure Kit Sterilization Tray
K192781
·
KCT
General Hospital
·
197d
Filters
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17
Gastroenterology & Urology
11
General & Plastic Surgery
4
General Hospital
2