510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1727
Chemistry
386
Dental
1394
Ear, Nose, Throat
256
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992
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2235
General Hospital
2093
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127
Immunology
104
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8
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474
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985
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444
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286
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3071
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52
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515
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2508
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156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
366
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Mask, Surgical
359
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Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
299
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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Regenesis Biomedical, Inc.
Medical Device Manufacturer
·
US , Scottsdale , AZ
Regenesis Biomedical, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1997
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Regenesis Biomedical, Inc.
Physical Medicine
✕
4
devices
1-4 of 4
Filters
Cleared
May 24, 2023
Reprieve by RegenesisTM
K223620
·
IMJ
Physical Medicine
·
170d
Cleared
Dec 13, 2013
PROVANT THERAPY SYSTEM
K131979
·
ILX
Physical Medicine
·
168d
Cleared
Apr 07, 2010
PROVANT SYSTEM, MODEL 4201
K091791
·
ILX
Physical Medicine
·
294d
Cleared
Oct 21, 1997
REGENESIS MODEL 42
K972093
·
ILX
Physical Medicine
·
139d
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4
Physical Medicine
4