510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
522
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1295
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18
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86
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870
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Xtreem Pulse, LLC
Medical Device Manufacturer
·
US , New York , NY
Xtreem Pulse, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Xtreem Pulse, LLC
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 06, 2025
PureLift GLOW
K243587
·
NFO
Neurology
·
106d
Cleared
Oct 21, 2022
PureLift Pro Plus
K221443
·
NFO
Neurology
·
156d
Cleared
Aug 28, 2019
PureLift
K190269
·
NFO
Neurology
·
201d
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4
Neurology
3
Cardiovascular
1