510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1335
Ear, Nose, Throat
245
Gastroenterology & Urology
964
General & Plastic Surgery
2190
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2900
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
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
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 04, 2015
CMOS Video Nasopharyngoscope System
K143673
·
EOB
Ear, Nose, Throat
·
70d
Cleared
Jan 27, 2015
SCHOELLY SINUSCOPE
K142249
·
EOB
Ear, Nose, Throat
·
166d
Cleared
Apr 09, 2014
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
K132009
·
EOB
Ear, Nose, Throat
·
282d
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12
General & Plastic Surgery
3
Obstetrics & Gynecology
3
Ear, Nose, Throat
3
Gastroenterology & Urology
2
Dental
1