510k
Database
Specialties
Anesthesiology
472
Cardiovascular
1417
Chemistry
334
Dental
1119
Ear, Nose, Throat
209
Gastroenterology & Urology
836
General & Plastic Surgery
1873
General Hospital
1379
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
807
Obstetrics & Gynecology
355
Ophthalmic
234
Orthopedic
2467
Pathology
48
Physical Medicine
429
Radiology
2047
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
LZA
Polymer Patient Examination Glove
252
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Radi Medical Systems AB
Medical Device Manufacturer
·
SE , Uppsala
Radi Medical Systems AB - FDA 510(k) Cleared Devices
24 submissions
·
24 cleared
·
Since 1990
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Radi Medical Systems AB
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 17, 2004
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291
·
QSY
General & Plastic Surgery
·
155d
Cleared
Sep 11, 1996
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
K962425
·
GAA
General & Plastic Surgery
·
79d
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24
Cardiovascular
21
General & Plastic Surgery
2
Radiology
1