Medical Device Manufacturer · US , Dallas , TX

American Medical Electronics, Inc. - FDA 510(k) Cleared Devices

14 submissions · 11 cleared · Since 1989

Total

Cleared

Denied

American Medical Electronics, Inc. has 11 FDA 510(k) cleared orthopedic devices. Based in Dallas, US.

Historical record: 11 cleared submissions from 1989 to 1995.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - American Medical Electronics, Inc.

14 devices

1-12 of 14

Cleared Aug 25, 1995

EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM

OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS

K951545 · HWC

Orthopedic · 95d

Cleared Feb 09, 1995

OGDEN ANCHOR-SMALL (TENTATIVE)

K941029 · JDR

Orthopedic · 339d

Cleared Feb 01, 1995

AME UNIVERSAL FIXATION SYSTEM

K931381 · KWP

Orthopedic · 685d

Cleared Jan 30, 1995

OGDEN ANCHOR ADDITIONAL APPLICATIONS

K935065 · JDR

Orthopedic · 467d

Cleared Jan 09, 1995

SILKON TITANIUM CABLE SYSTEM

K942300 · JDQ

Orthopedic · 242d

Cleared Jul 12, 1994

OGDEN ANCHOR (MODIFICATION)

K935167 · JDR

Orthopedic · 258d

Cleared May 03, 1994

AME(R) UNIVERSIAL CABLE SYSTEM

K932687 · JDQ

Orthopedic · 334d

Cleared Feb 22, 1994

AME UNIVERSAL BONE SCREW

K930107 · HWC

Orthopedic · 407d

American Medical Electronics, Inc. - FDA 510(k) Cleared Devices

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