510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2176
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
959
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2844
Pathology
52
Physical Medicine
515
Radiology
2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Spintech, Inc.
Medical Device Manufacturer
·
US , Minneapolis , MN
Spintech, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1992
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spintech, Inc.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 02, 2003
SAFETYWAND DISPOSABLE HANDPIECE
K023722
·
EJI
Dental
·
301d
Cleared
May 11, 2000
WAND PLUS
K992819
·
EJI
Dental
·
265d
Cleared
Jul 05, 1996
THE WAND
K961648
·
EJI
Dental
·
67d
Cleared
Feb 08, 1996
SHORTSTOP DISPOSABLE PROPHY ANGLE
K955654
·
EFB
Dental
·
58d
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10
Dental
4
Radiology
3
General Hospital
2
Orthopedic
1