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510k Database
Manufacturers
US
Ameritek, Inc.
Medical Device Manufacturer
·
US , Miami , FL
Ameritek, Inc. - FDA 510(k) Cleared Devices
17 submissions
·
17 cleared
·
Since 1986
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ameritek, Inc.
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 20, 1986
RK VACUUM FIXATION RING SYSTEM
K863775
·
HNH
Ophthalmic
·
24d
Cleared
Sep 25, 1986
SURGICAL IOP MONITOR
K863235
·
HKX
Ophthalmic
·
35d
Cleared
Mar 31, 1986
RARE EARTH INTRA-OCULAR MAGNET
K860960
·
HPN
Ophthalmic
·
18d
Cleared
Mar 31, 1986
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013
·
KYG
Ophthalmic
·
13d
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17
Chemistry
6
Toxicology
6
Ophthalmic
4
Hematology
1