510k
Database
Specialties
Anesthesiology
484
Cardiovascular
1476
Chemistry
340
Dental
1160
Ear, Nose, Throat
216
Gastroenterology & Urology
852
General & Plastic Surgery
1930
General Hospital
1468
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
834
Obstetrics & Gynecology
368
Ophthalmic
249
Orthopedic
2539
Pathology
49
Physical Medicine
452
Radiology
2088
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
285
GEI
Electrosurgical, Cutting &...
267
QIH
Automated Radiological Image...
258
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
208
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
175
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Roseburg SA
Medical Device Manufacturer
·
US , Washington , DC
Roseburg SA - FDA 510(k) Cleared Devices
24 submissions
·
23 cleared
·
Since 1985
24
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roseburg SA
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 21, 1987
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
K872714
·
GBI
General & Plastic Surgery
·
11d
Cleared
Dec 13, 1985
PORTASPIR II
K851560
·
BTA
General & Plastic Surgery
·
241d
Cleared
Apr 30, 1985
SURGICAL CAP CALOT
K851558
·
FYF
General & Plastic Surgery
·
14d
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All
24
Ophthalmic
8
General Hospital
4
Physical Medicine
3
General & Plastic Surgery
3
Orthopedic
3
Obstetrics & Gynecology
1
Chemistry
1
Dental
1