510k
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525
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1612
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356
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1304
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235
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928
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2135
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1991
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126
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91
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449
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2704
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52
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515
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2334
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155
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Polymer Patient Examination Glove
403
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System, Image Processing,...
370
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357
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351
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Electrosurgical, Cutting &...
295
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Automated Radiological Image...
275
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System, Imaging, Pulsed Doppler,...
266
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Plate, Fixation, Bone
262
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Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Safepath Medical, Inc.
Medical Device Manufacturer
·
US , Amesbury , MA
Safepath Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Safepath Medical, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
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Cleared
Oct 18, 2024
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide...
K222944
·
GAP
General & Plastic Surgery
·
753d
Cleared
Jun 25, 2018
SafePath Suturing System
K180701
·
GAP
General & Plastic Surgery
·
101d
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2
General & Plastic Surgery
2