Medical Device Manufacturer · US , Findley , MN

Spectramed, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1987

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spectramed, Inc. Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Jan 19, 1990

AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED

Obstetrics & Gynecology · 87d

Cleared Oct 24, 1989

MODEL DT-BAL, BALANCE SAVER

Obstetrics & Gynecology · 56d

Cleared Aug 15, 1989

MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP

Obstetrics & Gynecology · 32d

Cleared Feb 01, 1989

AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.

Obstetrics & Gynecology · 274d