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
Neurology
568
Obstetrics & Gynecology
242
Ophthalmic
154
Orthopedic
2042
Pathology
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
Browse all 339 categories →
Search
Reports
About
Home
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.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910
·
HWC
Orthopedic
·
24d
Cleared
Mar 01, 2000
STAPLETAC2 BONE ANCHOR SYSTEM
K000279
·
MBI
Orthopedic
·
30d
Cleared
Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332
·
MBI
Orthopedic
·
90d
Filters
Filter by Specialty
All
72
Gastroenterology & Urology
45
Obstetrics & Gynecology
11
General & Plastic Surgery
10
Orthopedic
3
Cardiovascular
2
General Hospital
1