510k
Database
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Anesthesiology
540
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1672
Chemistry
362
Dental
1335
Ear, Nose, Throat
245
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964
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2190
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2043
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126
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97
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8
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466
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965
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433
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274
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2900
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52
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515
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2433
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Schoelly Fiberoptic GmbH
Medical Device Manufacturer
·
US , Ayer , MA
Schoelly Fiberoptic GmbH - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1999
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Schoelly Fiberoptic GmbH
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 09, 2016
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
K151308
·
FGA
Gastroenterology & Urology
·
267d
Cleared
Aug 05, 1999
FLEXISCOPE IQ 101
K992362
·
FET
Gastroenterology & Urology
·
21d
Filters
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All
12
Ear, Nose, Throat
3
General & Plastic Surgery
3
Obstetrics & Gynecology
3
Gastroenterology & Urology
2
Dental
1