510k
Database
Specialties
Anesthesiology
494
Cardiovascular
1531
Chemistry
348
Dental
1207
Ear, Nose, Throat
223
Gastroenterology & Urology
887
General & Plastic Surgery
2015
General Hospital
1565
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
438
Neurology
875
Obstetrics & Gynecology
387
Ophthalmic
255
Orthopedic
2615
Pathology
49
Physical Medicine
473
Radiology
2185
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
329
LLZ
System, Image Processing,...
324
LZA
Polymer Patient Examination Glove
303
GEI
Electrosurgical, Cutting &...
280
QIH
Automated Radiological Image...
266
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
202
MAX
Intervertebral Fusion Device...
189
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American Safety Equipment Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
American Safety Equipment Corp. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1976
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Safety Equipment Corp.
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
Nov 19, 1976
SURGICAL MICRO DRILL
K760956
·
DZA
Dental
·
18d
Cleared
Nov 19, 1976
SURGICAL WIRE DRIVER
K760960
·
DZJ
Dental
·
18d
Cleared
Nov 16, 1976
SURGICAL OSCILLATING SAW
K760958
·
DZH
Dental
·
15d
Cleared
Nov 15, 1976
SURGICAL RECIPROCATING SAW
K760957
·
DZH
Dental
·
14d
Cleared
Nov 15, 1976
SURGICAL CHISEL
K760959
·
EMM
Dental
·
14d
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7
Dental
5
Hematology
1
Orthopedic
1