510k
Database
Specialties
Anesthesiology
436
Cardiovascular
1327
Chemistry
327
Dental
1019
Ear, Nose, Throat
192
Gastroenterology & Urology
789
General & Plastic Surgery
1734
General Hospital
1135
Hematology
117
Immunology
84
Medical Genetics
7
Microbiology
413
Neurology
743
Obstetrics & Gynecology
326
Ophthalmic
202
Orthopedic
2384
Pathology
44
Physical Medicine
397
Radiology
1922
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
285
LLZ
System, Image Processing,...
272
QIH
Automated Radiological Image...
247
GEI
Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
180
MAX
Intervertebral Fusion Device...
165
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Scanditronix Medical AB
Medical Device Manufacturer
·
SE , Uppsala S-754 50
Scanditronix Medical AB - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1997
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scanditronix Medical AB
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 05, 2001
OMNIDOS
K011763
·
IYE
Radiology
·
90d
Cleared
Sep 05, 2000
INVIDOS
K002051
·
IYE
Radiology
·
61d
Cleared
May 28, 1999
DPD-12PCC
K990734
·
IYE
Radiology
·
84d
Cleared
Jan 03, 1997
RFA-300, LDA UTILITY
K961400
·
IYE
Radiology
·
267d
Filters
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4
Radiology
4