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Polymer Patient Examination Glove
424
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407
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371
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361
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318
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System, Imaging, Pulsed Doppler,...
307
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Plate, Fixation, Bone
301
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
241
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Intervertebral Fusion Device...
237
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Manufacturers
US
Btl
Medical Device Manufacturer
·
US , Malborough , MA
Btl - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2019
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Btl
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 26, 2021
BTL-899ST
K202199
·
GEI
General & Plastic Surgery
·
174d
Cleared
Aug 21, 2020
BTL-785F
K193201
·
GEI
General & Plastic Surgery
·
275d
Cleared
Dec 05, 2019
BTL-899
K192224
·
GEI
General & Plastic Surgery
·
111d
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4
General & Plastic Surgery
3
Physical Medicine
1