510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2200
General Hospital
2052
Hematology
126
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99
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8
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472
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967
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436
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279
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2952
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52
Physical Medicine
515
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2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
228
MAX
Intervertebral Fusion Device...
220
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Wellspect AB
Medical Device Manufacturer
·
SE , M?lndal
Wellspect AB - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wellspect AB
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 24, 2026
LoFric Elle Pro
K260999
·
EZD
Gastroenterology & Urology
·
29d
Cleared
Sep 26, 2025
LoFric Origo
K250659
·
EZD
Gastroenterology & Urology
·
205d
Filters
Filter by Specialty
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2
Gastroenterology & Urology
2