510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1666
Chemistry
362
Dental
1334
Ear, Nose, Throat
245
Gastroenterology & Urology
963
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2186
General Hospital
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
Ophthalmic
274
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2886
Pathology
52
Physical Medicine
515
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2431
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
353
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Sunrise SA
Medical Device Manufacturer
·
BE , Namur
Sunrise SA - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sunrise SA
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 29, 2025
Sunrise
K250874
·
QRS
Anesthesiology
·
158d
Cleared
Dec 22, 2022
Sunrise
K222262
·
QRS
Anesthesiology
·
147d
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Anesthesiology
2