510k
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Anesthesiology
510
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1585
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355
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1279
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234
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922
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2111
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1873
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126
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91
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449
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421
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2681
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50
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507
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2294
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154
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Polymer Patient Examination Glove
386
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System, Image Processing,...
358
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Powered Laser Surgical Instrument
347
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292
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Mask, Surgical
279
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Automated Radiological Image...
272
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System, Imaging, Pulsed Doppler,...
263
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Plate, Fixation, Bone
260
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Orthopedic Stereotaxic Instrument
217
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Abutment, Implant, Dental,...
204
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Directed Systems, Ltd.
Medical Device Manufacturer
·
GB , Cambridge
Directed Systems, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Directed Systems, Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 23, 2021
Hypotension Decision Assist Model HDA-OR2
K212529
·
DXG
Cardiovascular
·
104d
Cleared
Nov 27, 2019
Hypotension Decision Assist
K190955
·
DXG
Cardiovascular
·
230d
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2
Cardiovascular
2