510k
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338
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1073
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272
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822
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149
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637
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1338
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770
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100
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72
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247
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2063
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311
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1591
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132
Categories
GEX
Powered Laser Surgical Instrument
231
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Plate, Fixation, Bone
211
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System, Imaging, Pulsed Doppler,...
209
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Automated Radiological Image...
208
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System, Image Processing,...
199
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Electrosurgical, Cutting &...
186
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Orthopedic Stereotaxic Instrument
170
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Abutment, Implant, Dental,...
161
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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HR Healthcare
Medical Device Manufacturer
·
US , York , PA
HR Healthcare - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2026
2
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - HR Healthcare
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 12, 2026
Liv Pre-lubricated Intermittent Catheter
K260502
·
EZD
Gastroenterology & Urology
·
27d
Cleared
Jan 29, 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274
·
EZD
Gastroenterology & Urology
·
280d
Filters
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2
Gastroenterology & Urology
2