510k
Database
Specialties
Anesthesiology
331
Cardiovascular
1056
Chemistry
268
Dental
798
Ear, Nose, Throat
148
Gastroenterology & Urology
621
General & Plastic Surgery
1314
General Hospital
747
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
365
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568
Obstetrics & Gynecology
242
Ophthalmic
154
Orthopedic
2042
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38
Physical Medicine
309
Radiology
1577
Toxicology
131
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
209
IYN
System, Imaging, Pulsed Doppler,...
208
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
198
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
154
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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American Medical Systems, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
American Medical Systems, Inc. - FDA 510(k) Cleared Devices
72 submissions
·
72 cleared
·
Since 1979
72
Total
72
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Medical Systems, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 30, 1984
VERIFORM II
K833583
·
DXN
Cardiovascular
·
110d
Cleared
Apr 29, 1982
THERMO-K
K820814
·
DWJ
Cardiovascular
·
36d
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72
Gastroenterology & Urology
45
Obstetrics & Gynecology
11
General & Plastic Surgery
10
Orthopedic
3
Cardiovascular
2
General Hospital
1