510k
Database
Specialties
Anesthesiology
492
Cardiovascular
1512
Chemistry
345
Dental
1195
Ear, Nose, Throat
221
Gastroenterology & Urology
873
General & Plastic Surgery
1981
General Hospital
1535
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
867
Obstetrics & Gynecology
381
Ophthalmic
254
Orthopedic
2598
Pathology
49
Physical Medicine
464
Radiology
2167
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
322
LLZ
System, Image Processing,...
321
LZA
Polymer Patient Examination Glove
296
GEI
Electrosurgical, Cutting &...
276
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
259
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
184
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Aspen Laboratories, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Aspen Laboratories, Inc. - FDA 510(k) Cleared Devices
55 submissions
·
55 cleared
·
Since 1976
55
Total
55
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aspen Laboratories, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 29, 1981
INFANT ECG ELECTRODE #60-1029
K810102
·
DRX
Cardiovascular
·
13d
Cleared
Jan 29, 1981
ADULT ECG ELECTRODE #60-0724
K810103
·
DRX
Cardiovascular
·
13d
Filters
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All
55
General & Plastic Surgery
37
Ear, Nose, Throat
10
Ophthalmic
2
Cardiovascular
2
Orthopedic
1
Obstetrics & Gynecology
1
Dental
1
General Hospital
1